LONDON—The British Medical Journal on Monday said GlaxoSmithKline PLC’s diabetes drug Avandia should never have been licensed and should be withdrawn from sale, a claim the company rejected.
An investigation by the journal found the U.K. Commission on Human Medicines in July advised the country’s drugs regulator, the Medicines and Healthcare products Regulatory Agency, or MHRA, to withdraw Avandia from sale because its risks outweigh its benefits.
The probe also found members of a European panel that reviewed the drug prior to its European Union-wide approval in 2000 had concerns about the long-term risks and benefits of Avandia, also known as rosiglitazone. The journal raised concerns about the quality of the data GlaxoSmithKline used to show Avandia didn’t lead to increased heart problems compared with other diabetes drugs.
Avandia was once Glaxo’s second-biggest drug, raking in about $3 billion a year. But its sales have plunged since a U.S. study linked it to heart attacks in 2007, and second-quarter revenue was only £152 million ($235 million) as patients defected to alternatives, such as Takeda Pharmaceutical Co.’s Actos.
Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug’s maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company’s $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to sealed court proceedings obtained by TIME.
What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies "strengthens the [cardiac-risk] signal observed in the [previous] analysis." Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an "increased risk of ischemic event ranging from 30% to 43%!" Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.
But the mixed-evidence argument GSK presented to the FDA worked. After months of deliberation, the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk.
Such examples of the drug industry’s outmaneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, the story of Avandia illustrates, is…
The post-2009 cyclical bull market in European equities is facing a critical test for survival – though, the writing may already be on the wall.
After last week’s Brexit bombshell, obviously all eyes are on Europe. It’s not that other markets, like the U.S., are not vulnerable. However, the current global contagion obviously began in Europe; therefore, the sooner the source can be contained, the better it will be for everyone. The question is, can the patient (Europe) make a recovery or is the situation terminal? In terms of the European equity bull market, we would not pull the plug just yet – ...
Well that didn't last long. With hopes of a face-ripping ride higher this morning as Draghi jawboning lifted bank stocks and Cable, the bounce was nothing but an opportunity for sellers to escape at better prices. While Deutsche eked out a tiny gain, RBS, Unicredit, Credit Suisse, and UBS all tumbled to end the day red...
And Cable has rolled over notably... back below 1.33!
Today the Richmond Fed Manufacturing Composite Index fell 6 points to -7 from last month's -1. Investing.com had forecast 2. Because of the highly volatile nature of this index, we include a 3-month moving average to facilitate the identification of trends, now at 2, still indicating expansion. The complete data series behind today's Richmond Fed manufacturing report (available here), which dates from November 1993.
Here is a snapshot of the complete Richmond Fed Manufacturing Composite series.
By Jacob Wolinsky. Originally published at ValueWalk.
Bill Gross on ‘What’d You Miss'”>Bill Gross on ‘What’d You Miss’
Streamed live 5 hours ago
Today on ‘What’d You Miss,’ co-hosts Scarlet Fu & Alix Steel bring you live coverage of the market close and talk to Standard & Poor’s Chief Global Economist Paul Sheard about the G7 meeting. We’ll also bring you Erik Schatzker’s interview with Bill Gross, live from FI16 in Los Angeles (http://la.bbgfi16.com/). We’ll hear from the bond king on central bank policy and his outlook for global growth.
‘What’d You Miss’ with Alix Steel, Scarlet Fu, and Joe Weisenthal airs every weekday on Bloomberg TV from 4 – 5 pm ET:
Global markets erased another $69.2 billion from the combined net worth of the worlds 400 richest people Monday, bringing the total since the U.K. shocked investors with a vote to leave the European Union to $196.2 billion in the last two trading days.
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I have mixed feelings about Brexit today. Clearly the European institution need reforming. The addition of so many countries in the last 20 years has created a top heavy administration. The Euro adds more complexities to the equation as the ECB policies cannot fit every country's problem. On the other hand, a unified Europe has advantages as well – some countries have benefited from the integration.
For Britain, it's hard to say what the final price will be. My guess is that Scotland might now vote for independence as they supported staying in Europe overwhelmingly. Northern Ireland might be tempted to leave as well so possibly RIP UK in the long run. I was talking to some French people and they were saying that now there might be no incentive for France to stop immigrants from crossing over to the UK like they do now and simply allow for travel there and let the UK deal with them. The end game is not clear to anyone at the moment....
One week ago, when bitcoin first crossed above $700 on the seemingly insatiable Chinese buying which we forecast last September (when bitcoin was trading at $230) would take place as a result of China's capital controls (to much pushback by the "mainstream" financial media), we tried to predict what may happen next. We said that "it could go much higher. That said, anyone who bought last September when the digital currency was trading at $230 may be advised to take some profits, and at least make...
After a three-year bull run that more than quadrupled its value by its peak last July, IBD’s Medical-Biomed/Biotech Industry Group plunged 50% by early February, hurt by backlashes against high drug prices and mergers that seek to lower corporate taxes.
This is a non-trading topic, but I wanted to post it during trading hours so as many eyes can see it as possible. Feel free to contact me directly at email@example.com with any questions.
Last fall there was some discussion on the PSW board regarding setting up a YouCaring donation page for a PSW member, Shadowfax. Since then, we have been looking into ways to help get him additional medical services and to pay down his medical debts. After following those leads, we are ready to move ahead with the YouCaring site. (Link is posted below.) Any help you can give will be greatly appreciated; not only to help aid in his medical bill debt, but to also show what a great community this group is.
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