A research study into the drug benfluorex (marketed as Mediator , which was withdrawn from the French market in 2009 because of side effects, shows that its use in France during 1976-2009 was probably responsible for around 1300 deaths and 3100 hospital admissions.
The study, published in
Pharmacoepidemiology and Drug Safety
, was carried out by Agnes Fournier and Mahmoud Zureik, two epidemiologists from the Institut National de la Sante et de la Recherche Medical (Inserm (2012, doi:
10.1002/pds.3213 .
They warn that these figures may be underestimates. Patients who took the appetite-suppressant drug experienced valvular insufficiency.
“We have worked with available data from hospitals activity monitoring and from Social Security reimbursements,” Dr Zureik explains. “The population we have studied consisted of 303?336 patients who had taken 78 million boxes of Mediator.” About 5 million people took the drug in the 33 years it was on the market.
The results are published at a difficult time for its manufacturer Servier, because the founder of the company Jacques Servier and his collaborators are due to appear in court in Nanterre, from 14 May to 6 July, to face charges of deception.
Monsieur Servier, and several other executives from his firm, are accused of knowingly hiding the side effects of benfluorex, a fenfluramine derivative drug marketed as an adjunct in the treatment of hyperlipidaemia.
This is only one of two legal cases facing the company. In the second case, which is underway in Paris, the company faces charges of “deception” and “unintentional injuries and manslaughter.”
Lawyers representing the victims of the drug say that it will cover the whole period during which benfluorex was on the market, and not just the past 10 years of its use. Servier’s lawyer has repeatedly asked for the two proceedings to be merged into one, but France’s highest court, the Court of Cassation, rejected this demand. A merger would postpone the trial for several years.
An earlier study of the drug showed that the relative risk of hospitalisation for valvular insufficiency in 2007-8 was 3.1 (95% confidence interval 2.4 to 4.0 among individuals with at least one prescription for benfluorex, compared with those without any prescription for it in 2006 (
Pharmacoepidemiol Drug Saf
2010;19:1256-62, doi:
10.1002/pds.2044 .
From another large scale study done in the US general population (
Lancet
2006; 368:1005-101, doi:
10.1016/S0140-6736(06 69208-8 , Fournier and Zureik conclude that “43% of individuals diagnosed through a clinically indicated echocardiography with a severe to moderate valvular heart disease will die prematurely because of that disease.” This enabled them to calculate that “1320 deaths due to valvular insufficiency are attributable to the use of benfluorex in France during the period 1976-2009.”
These figures may underestimate the number of deaths as well as the “real mortality risk ratio among benfluorex users ever hospitalised for valvular insufficiency,” say the two authors.
Notes
Cite this as:
BMJ
2012;344:e996
The US Food and Drug Administration is getting ready to review generic biotech drugs for the first time.
In advance of this, it released on 10 February 2012 guidelines under which the review process will be carried out. For consumers, the move represents the chance to obtain these hi-tech drugs - which presently command high prices - much more cheaply as so-called ‘biosimilars'.
The 2010 Patient Protection and Affordable Care Act featured one section calling for a biosimilar drug approval channel to open up but stated the FDA should be responsible for its content.
Draft Biotech Drug Guidelines
The draft biotech drug approval guidelines now release represent the administration's response to this call and they cover several areas. These include ‘Scientific Considerations', which supplies information to help generic biotech drug manufacturers prove that their products resemble those on which they're based. Also focused on are ‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product'.
"When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process", Janet Woodcock from the administration's Center for Drug Evaluation and Research explained in a statement. She added: "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
Generic Biotech Drug Approval
Responding to the news of these generic biotech drug approval guidelines' release, manufacturers expressed content and a statement issued by GPhA - the Generic Pharmaceutical Association sums up their feelings.
"GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients", the organisation said.
According to IMS Health, the worldwide biosimilars market has the potential to reach $25bn in value by 2020, thereby occupying a 10 per cent share of the overall biotech drugs market.
From here, the FDA's guidelines will be open for 60 days consultation, then firmed-up before being re-released in final form.
See also:
Companies supplying
Biotechnology
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A group of consumers has filed a class-action lawsuit against Japanese pharmaceutical company Astellas Pharma for presenting what they say is a "sham" petition to the U.S. Food and Drug Administration (FDA to extend the market exclusivity period for its transplant drug... |
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JEFFREY BROWN: Now to Italy. Like Greece, it's under pressure from international creditors to bring down its massive national debt. But its economy is so big that an Italian default could bring about the collapse of the entire euro system.
Margaret Warner wraps up two weeks of reporting on the European debt story with this report from northern Italy on a country confronting the threats to its economy and much more.
MARGARET WARNER: Long before models float down the runways in Milan, fashion designers flock here, the biannual Milan textile fair. But this year's display of fabric, bolts and buyers belies the fact that this cornerstone of Italian industry is struggling.
Third-generation thread-maker Roberto Belloli says Italian materials, design and craftsmanship are in a dogfight, competing globally against cheaper goods, and using the euro means Italy can't devalue to compete on price, as it did in the days of the lira.
And now there's another threat, the eurozone crisis. Belloli has to turn away longtime customers at home and abroad because they're short of cash for credit.
ROBERTO BELLOLI, CEO, Antonio Aspesi, SRL: We had a good company with some customers in Greece. And, in this moment, it's not possible to work with them, for example, or in Spain, or in Portugal, because, in this moment, they have no credit. So we had to reduce this company. So, we cannot work with them.
MARGARET WARNER: All of Italy is hurting, from the fashion and financial hub of Milan to the country's many small towns, business is bad.
GIULIO COTI ZELATI, cafe owner (through translator : Earnings have changed. What's in the drawer at the end of the day, it is very easy to work a lot and earn very little.
MARGARET WARNER: We came from Germany to the prosperous north Italian region of Lombardy to see why Italy's economy is losing ground. The stakes here are enormous. Europe's second most indebted country after Greece, Italy's too big to bail out. But, as the world's seventh largest economy, it's too big to fail.
TITO BOERI, Bocconi University: The increasing Italian public debt occurred mostly in the '80s, beginning of the '90s.
Economist Tito Boeri, a professor at Bocconi University, says Italy incurred the debt through government giveaways two decades ago. But its biggest problem in tackling the debt now is the last 10-plus years of stagnant growth.
TITO BOERI: The income per capita, so the average income of an Italian is now in 2012 at the level of 1999. The reason behind this is structural, but what we call structural problems, structured impediments to growth.
MARGARET WARNER: That was clear during a visit to Italy's Lake District. Known for its alpine views, it's also home to an age-old manufacturing sector.
ARISTIDE STUCCHI, CEO, AAG Stucchi: We are very family-oriented people. And we are very attached to the ground where we are born.
MARGARET WARNER: Aristide Stucchi owns a lighting component firm founded by his grandfather. He feels hamstrung by a labor law that makes it extremely hard for most companies to fire a worker.
ARISTIDE STUCCHI: If the judge do not think that the reason to fire him was good, you must re-put him in place and pay him the salary of up to 60 months.
MARGARET WARNER: You go to court. How long does that whole process take?
ARISTIDE STUCCHI: A life. A life, yes.
MARGARET WARNER: But does that inhibit you in any way from hiring?
ARISTIDE STUCCHI: Yeah, that's the biggest problem now, probably, that companies think twice to hire somebody.
MARGARET WARNER: Just up the road is a family-run chain-making company. Its owner, Giovanni Maggi, feels held back by a swollen and unresponsive Italian bureaucracy.
GIOVANNI MAGGI, CEO, Maggi Group: The bureaucracy, which has a very negative effect in the economy in Italy, gave us a lot of problems, so we need a lot of permission.
MARGARET WARNER: Permitting hassles long delayed his plans to build this simple warehouse across the parking lot.
GIOVANNI MAGGI: In the last two years, nowadays, it's not possible because we are in a global market, with competition from all the world, and we must be very fast in reaction.
MARGARET WARNER: And then there is Italy's high rate of corporate taxation. Combined taxes can run more than 50 percent. Stucchi and Maggi argue that's one reason Italian companies aren't as efficient as some foreign competitors. It also leads to tax evasion.
The reasons for the Italian sport of tax dodging has even deeper roots, Maggi says.
GIOVANNI MAGGI: I think maybe it was, you know, in the mentality of the Italians. I think that most of the Italians, they don't believe the state, and most of the Italians, I'd say they like in their DNA that do not pay taxes. But this one doesn't work, I think. So we must pay taxes if we want that our country will be able to survive.
MARGARET WARNER: Economist Boeri says the underground economy is so pervasive, an estimated 30 percent of total output, that it spawned its own vocabulary.
TITO BOERI: We have the black economy and the cappuccino economy. The cappuccino is . . .
MARGARET WARNER: What's the cappuccino economy?
TITO BOERI: The cappuccino is with some milk. No, it is a color that is less black.
MARGARET WARNER: So a restaurant might declare some of its receipts, but not all?
TITO BOERI: Exactly. This would be a cappuccino type of situation.
MARGARET WARNER: Italy's stalled economy has been devastating for many ordinary Italians. Most young people aren't hired full-time these days, but under short-term contracts, giving employers little incentive to train them.
Thirty-three-year-old architect Francesco Leoncavallo juggles two jobs, just one in his field.
FRANCESCO LEONCAVALLO, architect: No contracts.
MARGARET WARNER: No contracts at all?
FRANCESCO LEONCAVALLO: No.
(through translator : In the evenings, I do a job which has no reference to what I studied.
MARGARET WARNER: And there are lots of newly poor.
The Caritas Catholic charity in Vimercate near Milan used to care mostly for immigrants. Now an increasing number seeking help are proud Italians, like pensioner Piera Raffaglio, who says her son and son-in-law both lost their jobs.
PIERA RAFFAGLIO, pensioner (through translator : My situation today is a disaster. There is more than one reason for it. Number one, the euro currency which entered Europe, it has made everything cost more.
MARGARET WARNER: Is it hard for to you come here?
Piuccia Piorola, who's run the center since it opened in 2000, says native-born Italians used to be just 3 percent of its cases. Now they're 35 percent.
PIUCCIA PIOROLA, director, Caritas of Vimercate (through translator : The problems affecting the families are unemployment, income and housing, but also family problems, conflicts, separations, single mothers. He or she who is poor always has other problems, too.
MARGARET WARNER: Yet, it was only last summer, as the global bond market started hammering Italy's interest rates, that Italians were forced to confront the trouble they were in. Under pressure from the markets and European Union leaders, like Germany's Angela Merkel and France's Nicolas Sarkozy, Prime Minister Silvio Berlusconi resigned and was replaced by unelected economist Mario Monti.
BEPPE SEVERGNINI, journalist: We decided that in an emergency we would need to rush to Dr. Monti emergency room, and that we could not fool around all night with good old Silvio and his people and his colorful entourage. And please note my understatement.
MARGARET WARNER: Italian journalists and author Beppe Severgnini says many Italians deep down welcomed intervention by their northern neighbors.
BEPPE SEVERGNINI: The reality was, we were going down the drain, down the -- we're going the Greece way. And that would be a disaster for us and for the rest of Europe and I think for the rest of the world.
MARGARET WARNER: In three months, Monti has pushed through spending cults, a hike in the retirement age and renewed taxes on primary residences. But there is resistance to his attempts to liberalize the economy from the grip of guilds that limit numbers and set minimum prices for pharmacists, lawyers, notaries and taxies.
Cabdriver Antonio Costa says he will have to work more for less money if more cabs hit the streets, while tax hikes have raised gas prices. He faults E.U. leaders for pressuring Monti without giving him much of a helping hand.
ANTONIO COSTA, cab driver (through translator : I believe Merkel could have done more for us economically, for example, euro bonds, which she refused to do and she should have. But Germany is the most powerful force. They hold the knife by the handle, so they can decide whether we have good weather or bad weather.
MARGARET WARNER: Are the Germans trying to dictate to Europe?
ANTONIO COSTA (through translator : Certainly. No doubt about it.
MARGARET WARNER: Polls show a majority of Italians, like consumer goods company manager Andrea Rendina, approve of what Monti's doing.
Do you think he's going to succeed?
ANDREA RENDINA, company manager: Provided he has the opportunity to continue working, yes, he will. Hopefully, he can do it, because, eventually, we have expert people at the right place.
BEPPE SEVERGNINI: The Italians have changed more in the last six months then they have in the last 15, 20 years. But Italy is an operatic country. Never forget that. And the crowd in the theater, they cheer the tenor until the very moment until they boo him off the stage.
MARGARET WARNER: Yet, with so much at stake, says Beppe Severgnini, perhaps bravos won't give way to boos too quickly this time.
BEPPE SEVERGNINI: Deep down, we know that is the only way to do things. Work longer. Do not waste money. Pay your taxes.
If we do that, then Italy is paradise. So, everything else is right. Look at a place like this. Look at a town like this. Look the food, the wine, the families we have. We have got everything all right.
MARGARET WARNER: All right indeed, but if Italians want to preserve the way of life they cherish, they are first going have to save it.
Some of our German readers may be laboring under the impression that following the ˆ110 billion first Greek bailout agreed upon and executed in May 2010, the second Greek bailout would cost a "mere" ˆ130 billion. Alas we have news for you - as of this morning, the formal cost of rescuing Greece for the adjusted adjusted adjusted second time has just risen to
ˆ145 billion
,
ˆ175 billion
, a whopping ˆ210 billion, bringing the total explicit cost of all Greek bailout funds to date (and many more in store to ˆ320 billion. Which incidentally is
a little
more than Greek GDP (which however is declining rapidly at 310 billion, only in dollars. So as of today, merely the ratio of the Greek DIP loan (Debtor In Possession, because Greece is after all broke has reached a whopping ratio of 136% Debt to GDP. This
excludes any standing debt
which is for all intents and purposes worthless. This is
secured debt
, which means that if every dollar in assets generating one dollar in GDP were to be liquidated and Greece sold off entirely in part or whole to Goldman Sachs
et al
, there would still be a 36% shortfall to the Troika, EFSF, ECB and whoever else funds the DIP loan (i.e., European and US taxpayers ! Another way of putting this disturbing fact is that global bankers now have a priming lien on 136% of Greek GDP - the entire country and then some now officially belongs to the world banking syndicate. Consider that when evaluating Greek promises of reducing total debt to GDP to 120% in 2020, as it would mean wiping all existing "pre-petition debt" and paying off some of the DIP. Also keep in mind that Greece has roughly ˆ240 billion in existing pre-petition debt, of which much will remain untouched as it is not held in Private hands (this is the debt which will see a major "haircut" - or not: all depends on the holdout lawsuits, the local vs non-local bonds and various other nuances
discussed here . If you said this is beyond idiotic, you are right. It is not the impairment on the Greek "pre-petition' debt that the market should be worried about - that clearly is 100% wiped out. It is how much the Troika DIP will have to charge off when the Greek 363 asset sale finally comes. This is also what Angela Merkel will say tomorrow when Greece shows up on its doorstep with the latest "revised" agreement from its parliament to take Europe's money ahead of the March 20 D-Day. Because finally, after months (and to think we did the math for Die Frau
back in July Germany has done the math, and has reached the conclusion that letting Greece go is now the cheaper option.
So how do we get to the ˆ210 billion number? Well, there is the ˆ130 billion already "agreed" upon.
- Then there is the additional ˆ15 billion which Spiegel
broke 2 weeks ago... New net second bailout : ˆ145 billion, and ˆ255 billion total.
- Then there is the fact that the ECB's bond swap into the EFSF for the 15 cent sweetener in "cash" equivalents to creditors has to be funded. As Credit Suisse's William Porter explains: "The ECB's reported bond swap has to be funded." Bingo. The WSJ further adds today, that according to a new 19-page bill, "An additional ˆ30 billion will be provided in the form of bonds issued by the EFSF and will be offered to private creditors as a "sweetener."" Ah, so another ˆ30 billion cost in the hole. Which incidentally begs the question- if the ECB is Europe's bad bank (courtesy of the potential $7.1 trillion collateral expansion
discussed here, just what the hell does that make the EFSF which is now the ECB's bad bank ... So new net second bailout: ˆ175 billion, and ˆ285 billion total.
And finally, and going back to the
WSJ's article, it appears that in addition to the ˆ30 billion in Ponzi accounting which will have to be funded from the EFSF so the ECB does not "profit" on its Greek bond holdings (can someone please
look at this chart and explain to us how the ECB can profit on this security .
Greece will borrow up to ˆ35 billion from Europe's temporary bailout fund to finance an ambitious debt-buyback plan from the European Central Bank, according to official documents released by the government Saturday.
The 19-page bill sets out how the restructuring will be implemented and includes a plan through which Greece will buy back those bonds now held as collateral in the national central banks of euro-zone countries.
The plan is part of a raft of new measures Greece must take to secure a ˆ130 billion bailout from its European partners and the International Monetary Fund, along with a ˆ100 billion debt write-down the country is negotiating with its private-sector creditors
The measures, which will be voted on in parliament Sunday, include sweeping reforms such as ˆ1.1 billion worth of cuts in pharmaceutical costs, abolishing restrictive rules on tourist guides and opening up Greece's energy market to foreign investment.
Who funds this latest and greatest addition to the monetary black hole that is Greece? Take a wild guess...
According to the bill, the European Financial Stability Facility, the euro zone's transitional rescue fund, will lend Greece the money to carry out the buyback. The ECB will act as an intermediary in this transaction, buying the bonds on Greece's behalf.
In other words, joint and several EFSF member countries such as Italy and Spain, oh and Greece of course, will be funding even more money to bail out Greece, only they won't be doing it, the ECB will... If your head is not spinning yet, you are not paying attention.
One person, whose head is most certainly not spinning and whose mind is long made up, is Angela Merkel. Who will promptly put an end to this lunacy as soon as the ball (bail? is back in her court officially, some time on Sunday. And all that is of course assuming that there are Greek member of parliament who have not resigned by the time tomorrow when Greece is now fully expected to pass this latest bill.
Finally ask yourselves this: what would have happened if Greece had been allowed to default in May 2010 and all debts wiped out, and instead of feeding its creditors, the funding sources had provided the country with ˆ320 billion in new debt (as they are anyway, only it is to make its creditors whole . It would mean that, assuming a dollar for dollar equivalency between GDP and debt, Greece would have grown by about 36% more in the past two years compared to where it is now, even with the occasional German submarine purchase. Something tells us the Greek people should have the right to know this.
Finally, a chart of what is coming to a Keynesian banana republic near you, or what it means when you can no longer mask insolvency in nominal terms.
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The
Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up.
In a
letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.
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