March 26, 2012
By Karin Munsterhjelm-Ahumada, M.D.
“If you thinks vaccines are safe – think again.” –KTRN
The swine flu pandemic of 2009 was caused by a type A influenza (H1N1) virus. This virus was originally referred to as “swine flu” because many of the genes of this new virus were very similar to influenza viruses that normally occur in pigs in North America. The H1N1 virus is genetically similar to the 1918 pandemic virus, as determined from victims of the latter who were buried, and later disinterred, in Svalbard. It was responsible for most of the outbreaks up until 1956 and then disappeared.
However, this new virus was actually quite different from the typical swine flu viruses. This virus first caused illness in Mexico and the United States in March and April, 2009. This novel H1N1 flu spread from person to person, unlike typical swine flu. In 2009 vaccines were being developed for the prevention of swine flu in humans. (Source)
On 11 June 2009, the World Health Organization (WHO) declared that the swine flu had developed into a full-scale world epidemic — a pandemic alert to Phase 6. Margaret Chan, the Director-General of WHO, commented on the situation in a somewhat ambiguous way. While stressing that the swine flu had reached a serious pandemic level, she declared later in the same statement that the illness seemed to be mild and that most of the patients would recover without medical intervention. (Source)
The world chose to listen to the first part of her message.
Two pharmaceutical companies GlaxoSmithKline (GSK) and Novartis had, under considerable time pressure, developed a vaccine against the swine flu. Since the cultivation of an adequate amount of virus to generate the vaccine requires time, GSK and Novartis decided to formulate a weaker vaccine but strengthen it with an adjuvant that contains squalene. Immunologic adjuvants are substances, administered in conjunction with a vaccine, that stimulate the immune system and increase the response to the vaccine.
January 24, 2012
By Katie Reid
“Poor little drug company. It seems there drugs don’t actually … work. Sorry about that guys.” –KTRN
Novartis AG plans to axe nearly 2,000 of its U.S. workforce ahead of the patent loss of top-selling blood pressure drug Diovan there and will take a $900 million charge after another of its key drugs failed to live up to expectations.
Novartis is the latest in a long line of global drugmakers to cut its sales force as the industry faces its biggest wave of patent expiries ever.
The Swiss drugmaker’s news comes just weeks after AstraZeneca said it was slashing nearly a quarter of its U.S. sales force in a second round of job cuts in as many months, while Sanofi has also said it is cutting back on its sales force there.
Novartis plans to shed 1,630 jobs in its U.S. field force and another 330 positions are expected to go as it reorganizes the headquarters of its U.S. general medicines business. The changes are expected to take place in the second quarter of this year.
Diovan, which sells $6 billion a year, went off patent in Europe last year and it will lose exclusivity in the United States this September. Japan follows in 2013.
The Basel-based group expects the restructuring measures, which will result in a one-off charge of $160 million in the first quarter of 2012, to claw back annual savings of around $450 million by 2013.
Novartis’ latest round of redundancies comes only a few months after it said it was cutting 2,000 jobs in Switzerland and the United States to keep costs under control in the face of growing price pressures.
The company has already cut thousands of jobs and shut several sites, notably in Britain. In 2010, it said it was cutting 1,400 jobs in the United States as it focuses increasingly on specialty medicines to boost profitability.
January 9, 2012
By Madison Park
Machinery problems at a drug manufacturing plant prompted the U.S. Food and Drug Administration to warn patients of a possible mix-up affecting various prescription pain medications and over-the-counter drugs.
The FDA is advising patients who use certain prescription medications produced by Endo Pharmaceuticals to visually inspect their pills. And consumers who have select bottles of Excedrin, Bufferin, NoDoz and Gas-X, produced by Novartis, are being told to discard or return the products in a voluntary recall that started Sunday.
The over-the-counter drugs involved in the recall were manufactured at a Lincoln, Nebraska, facility which also produced various prescription pain medicines for Endo Pharmaceuticals, according to the U.S. Food and Drug Administration. These pills include Percocet, Opana and Percodan.
“Due to problems that occurred when these products were packaged and labeled at the site, it’s possible that tablets from one product may have been retained in the packaging machinery and then may have carried over into the packaging of another product,” said Dr. Edward Cox, director of the Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation of Research for the FDA.
“This could result in an incorrect pill ending up in the bottle of another product. The likelihood of this occurring in medication dispensed in patients is estimated to be low,” he added.
The prescription opioids could have ended up in the bottle of another prescription drug or over-the-counter products, although “the risk of pills ending up in the wrong bottle is a rare event,” according to the FDA.
There have been no reports of adverse events due to this problem, Cox said.
January 17th, 2011
By: Catherine Donaldson-Evans
New evidence has surfaced adding fuel to the theory that several common prescription and over-the-counter pain drugs may increase the risk of heart attack and stroke.
Among those targeted in the study by Swiss researchers: ibuprofen (sold as Advil, Motrin), naproxen (sold as Aleve) and prescription drugs including Celebrex and Vioxx, which has been withdrawn from the market in the U.S. over safety concerns.
Scientists from Bern University in Switzerland analyzed the findings of 31 trials covering more than 116,000 people taking one of the following pain medications: naproxen, ibuprofen, diclofenac, Celebrex made by Pfizer (celecoxib), Arcoxia made by Merck (etoricoxib), Merck’s Vioxx (rofecoxib), Prexige by Novartis (lumiracoxib), or a placebo.
They were looking at older non-steroidal anti-inflammatory drugs, known as NSAIDS, and a newer set called COX-2 inhibitors to measure heart disease and stroke risks.
Ultimately, what they found was that while the painkillers’ chances of contributing to cardiovascular disease were relatively low, there were still significant risks — except with naproxen according to their study published Wednesday in the British Medical Journal.
“Naproxen in multiple studies has not [been shown to have a risk],” said AOL Health’s cardiology expert Dr. Christopher Cannon. “That is definitely the first drug of choice to use. That’s a very strong take-home message.”
The team led by Peter Juni, of the Institute of Social and Preventive Medicine at Bern, said that Vioxx and Prexige had double the risk of heart attack as a placebo, and taking ibuprofen more than tripled the risk of having a stroke.
Cardiovascular-related death was four times more likely in patients taking Arcoxia and diclofenac, the authors said.
“Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms,” said Juni, according to Reuters.
He said doctors should be careful before suggesting or prescribing painkillers to patients and must consider the heart disease and stroke risks associated with them.
Still, the rate of cardiovascular conditions was relatively low in the participant pool, with only 554 heart attacks, 377 strokes and 676 deaths among the 116,000 participants.
Both NSAIDs and COX-2 inhibitors have been under scrutiny for their risk of heart problems.
The Swiss scientists said naproxen seemed to be the least risky painkiller, though it can upset the stomach and even cause ulcers and bleeding. Celebrex, taken in 400-milligram increments once a day, is a good second choice, they concluded.
Cannon, who took part in one of the trials the scientists used for their analysis, said there are specific reasons for naproxen’s benefits. But he disputed the researchers’ recommendation to take Celebrex as an alternative if stomach troubles persist with Alleve.
“Naproxen has an anti-clotting effects, similar to the way aspirin does. That may be how it is protective,” he told AOL Health. “I would counter [the suggestion to use Celebrex]. It’s been a little less studied … but Celebrex has similar risks to Vioxx and the others, so one has to be aware of that.”
Previous studies have provided mixed results on the drugs’ potential link to cardiovascular problems, according to the researchers. Vioxx was pulled from shelves in 2004 after one clinical trial revealed a higher risk of heart attack in those taking it.
December 15th, 2010
The Wall Street Journal
By: Alicia Mundy
Congress’s watchdog arm has criticized the Food and Drug Administration for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.
On Tuesday, a congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.
Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG’s Sandoz unit.
Also critical of the FDA’s actions are Momenta’s rivals—including Teva Pharmaceutical Industries Ltd., the world’s largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA’s generic-drug division. The drug companies’ applications are still awaiting FDA action.
The controversy centers around Momenta’s performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company’s application to sell the generic version of a blockbuster blood thinner.
As a result, “agency officials ran the risk of undermining public confidence in the integrity of FDA’s operations,” including heparin-related drug approvals, the report says, according to a copy reviewed by The Wall Street Journal.
In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta’s expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.
The FDA has said its reliance on Momenta’s free work had nothing to do with its approval of the company’s drug ahead of competitors’.
Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.
Momenta’s newly approved product is a generic version of a fast-acting form of heparin. Until the July approval, Sanofi-Aventis SA’s Lovenox drug had a monopoly on that market, with world-wide sales last year that topped $4 billion.
Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug’s sales have topped $300 million.
The small biotech company doesn’t have other marketed products.
Teva officials told the Journal that the company met with the FDA in October and raised questions about possible bias. It has said its application, which was filed two years before Momenta’s, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs.
Amphastar filed the first application to make generic Lovenox in 2003. It says the FDA told it in late 2007 that it met the standards for “sameness” but then the standards changed. The company sued the FDA in October, alleging favoritism.
Richard Adams, a former official in the FDA’s generic-drug division who retired this year, agreed with the bias allegation . “Everyone closely involved saw that it was stacked and the whole direction was toward Momenta,” he said.
Momenta’s chief executive, Craig Wheeler, has said that the company’s science for copying complex drugs such as Lovenox surpasses that of other companies. Its scientists have spent more than a decade developing ways to pinpoint the molecular structure of Lovenox, he said.
The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.
The FDA said that Momenta’s researchers did an excellent job identifying the contaminant. “This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists,” it wrote in a response to the GAO.
Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency’s “fundamental weakness” in dealing with the surge of Chinese medical imports.
October 7th, 2010
By: Eva von Schaper
Novartis AG agreed to use technology from Synthetic Genomics Vaccines Inc., a company run by genome pioneer Craig Venter, in an effort to cut the time needed to develop influenza shots.
Novartis and San Diego-based Synthetic Genomic Vaccines will work together to create so-called seed viruses, templates from which large amounts of vaccine are created, Novartis said in a statement today. Novartis hopes to reduce the time needed to start vaccine output by two months, which is critical in the case of a flu pandemic, the company said.
“There is always the risk a of pandemic,” Rino Rappuoli, who heads vaccine research at Basel, Switzerland-based Novartis, said in a telephone interview today. The company produced enough vaccine only after the peak of the flu pandemic was over last year, Rappuoli said.
The companies agreed to a three-year collaboration, according to the statement. The work is supported by the U.S. Biomedical Advanced Research and Development Authority, the government agency that oversees vaccine and drug development for public-health emergencies.
Vaccine manufacturers rely on the World Health Organization to identify and distribute live reference viruses to create seasonal or pandemic shots. Novartis and Synthetic Genomics will work to develop a bank of synthetically constructed seed viruses ready to go into production as soon as WHO identifies a new flu strain, the company said.
“We will have all the pieces ready to go, and on the day we will just push the button,” Rappuoli said.
The bank could be ready as early as next year, Rappuoli said. While Novartis is concentrating on a pandemic flu shot, the collaboration may also benefit its seasonal flu program, according to Siena-based Rappuoli.
Venter is best known for his privately backed race in 2000 against the publicly funded Human Genome Project to decode the entire human genetic blueprint. The teams shared credit for the milestone. This year, researchers at the J. Craig Venter Institute in Rockville, Maryland, reported that they made a copy of a bacterium’s entire genome and then transplanted it into a related organism, where it functioned normally.
Synthetic Genomics Vaccines was created by the not-for- profit Venter institute and Synthetic Genomics Inc., a company Venter founded in 2005. Investors in Synthetic Genomics Inc. include BP Plc and the venture-capital firm Draper Fisher Jurvetson.
May 20, 2010
By Rachel Cooper
Advair, which is known as Seretide in Europe and Viani in Germany, made up 18pc of Glaxo’s sales last year with £5bn worth of the drug being sold across the world.
Germany, which is Europe’s biggest pharmaceutical markets, accounted for £177m of Advair sales. Thursday’s court ruling, which marks a victory for four generic drug-makers including a unit of Novartis’ Sandoz, deemed that the German patent covering the combination of ingredients in the drug was invalid.
The ruling only applies to the drug in Germany and cannot be applied elsewhere but it marks the latest in a series of challenges to the patent.
March 23, 2010
The Food and Drug Administration said Friday the highest available dose of Zocor, a component in cholesterol drugs, can cause muscle damage as well as severe and potentially lethal kidney damage.
The agency said statin drugs like Zocor are known to cause muscle damage in some patients, but the risk is more severe when patients are taking 80 milligram doses of Zocor, which is the highest FDA-approved dose.
The side effects include rhabdomyolysis, a form of muscle damage that can lead to kidney damage or failure, and death.
Zocor is the brand name for the drug used by Merck & Co. of Whitehouse Station, N.J. Its chemical name is simvastatin.
Simvastatin, which is also part of Merck’s cholesterol drug Vytorin and Abbott Laboratories’ drug Simcor, is sold by 11 other generic drug makers including Dr. Reddy’s Laboratories, Teva Pharmaceutical Industries, and Novartis’ Sandoz division.
FDA-approved doses of Zocor range from 5 milligrams to 80 milligrams.
The FDA said the warning is based on clinical trials, studies, reports of side effects by users and prescription data.
March 17, 2010
By: Charlene Laino
Better heart treatment of women could help close the gender gap in heart deaths. Women would be more likely to survive a heart attack if they were treated more like men, French researchers say.
In a study of more than 3,500 people admitted to the hospital for a heart attack, women were far less likely than men to get angiography to visualize heart artery blockages or angioplasty to open up blocked arteries.
Women were about twice as likely to die within a month of having the heart attack, according to the study, presented at the American College of Cardiology’s annual meeting.
The higher death rate in women “is related to the fact that they don’t get the same treatments as men,” says Maria Rosa Costanzo, MD, an American Heart Association spokeswoman who was not involved with the study.
“If women had the same access to procedures and medication as men, they would derive the same benefit,” says Costanzo, of Midwest Heart Specialists in Naperville, Ill.
Study researcher Francois Schiele, MD, chief cardiologist at the University Hospital of Besancon in France, says that when possible, “women should be treated with all recommended strategies, including invasive ones.”
Closing the Gender Gap
Costanzo tells WebMD that it’s been known for some time that women fare worse after a heart attack than men, but it’s been unclear why. Some studies point to biological differences such as women’s smaller blood vessels that raise the risk of complications during angioplasty, she says.
Also, women tend to be older and have poorer overall health when they have heart attacks, and wait longer to seek medical care than men, research suggests.
But other studies suggest that women are undertreated, Costanzo says.
The new study attempted to level the playing ground by using statistical techniques that took into account women’s and men’s different characteristics and treatments when they had heart attacks.
The researchers analyzed data from a regional registry that included more than 3,500 patients, about a third of whom were women, treated for a heart attack between January 2006 and December 2007.
Women were, on average, nine years older than men, had more health problems, and received fewer effective treatments for heart attack. They were nearly twice as likely to die, both during the initial hospital stay and over the following month.
When the analysis was adjusted to take into account the differences in the women’s ages, blood pressure, kidney function, and other characteristics as well as the treatments they received, there was no difference in death rates, either in the hospital or at 30 days.
“Once they compared apples to apples, it shows women get the same benefit from [procedures to open blocked arteries] and medication as men,” Costanzo says.
Drugmakers GlaxoSmithKline, Novartis, and Sanofi-Aventis helped fund the registry.
March 10, 2010
The Dutch government wants to sell 21 million unused H1N1 flu vaccine doses back to their manufacturers after they proved unnecessary and no other country wanted to buy them, the Health Ministry said on Saturday.
A spokeswoman for the ministry said it had approached manufacturers GlaxoSmithKline and Novartis about buying back the doses.
She added that it was not clear what their total value was. She also declined comment on the status of the talks, saying the ministry would inform parliament of the details at a later date.
At the height of the H1N1 scare, the ministry ordered 34 million doses of pandemic flu vaccine — enough to give two shots to every person in The Netherlands.
Of the original order, about 11 million doses were administered and another 2.2 million are being kept in reserve for emergencies.