Avandia negative data – “Why would you publicize it?” says JP Garnier

More on Glaxo and Avandia – Andrea Gerlin at Bloomberg continues to investigate the drug maker and its latest problem medicine:

Glaxo, Top Ad Spender, Didn’t Publicize Avandia Risks
GlaxoSmithKline Plc was the drug industry’s top advertiser last year [2006], promoting its asthma and diabetes treatments to patients and doctors. Information the company didn’t make well known is now drawing more attention.

London-based Glaxo knew its Avandia diabetes pill posed a risk for heart and circulatory complications as early as 1999, when the medicine won U.S. approval. The cardiovascular concern wasn’t widely disseminated until May 21 [2007] when a Cleveland Clinic Foundation analysis reported that Avandia may cause a 43 percent higher risk of heart attacks than other drugs.

A similar review, begun in 2005 by Glaxo, found that Avandia raised the risk of reduced blood flow to the heart, including heart attacks, by 31 percent. The company gave the review to U.S. regulators and put it on its Web site last year amid more than 2,000 studies. Glaxo says the heart-risk studies, including its own, are flawed and it isn’t obligated, or legally required, to highlight every study done on its drugs.

“Why would you publicize it?,” Glaxo Chief Executive Officer Jean-Pierre Garnier told reporters at the company’s annual meeting May 23 in London. “We don’t publicize every submission we make to the Food and Drug Administration.”

Glaxo, the world’s second-largest drugmaker after New York- based Pfizer Inc., spent $849 million on consumer advertising last year, the most of any pharmaceutical company, according to Nielsen Monitor Plus, a unit of New York-based Nielsen Media Research Inc.

$3 Billion in Sales
Avandia generated $3 billion for Glaxo last year, or 7 percent of total sales, and at least $12 billion since 1999. Analysts had estimated sales of $4 billion in 2007. The medicine helps the body better use insulin to lower high blood sugar, which in excessive amounts can cause complications such as heart disease, and kidney and eye damage. Glaxo says the treatment has risks similar to other oral diabetes medicines.

By 2005, the drugmaker had spent almost $200 million on advertisements advising U.S. consumers to ask their doctors about Avandia, its second best-selling product. Advertising included warnings contained in prescribing information, such as “Avandia may cause fluid retention or swelling, which can make some heart problems worse or lead to heart failure,” from a 2005 television commercial.

The Cleveland Clinic report released in the New England Journal of Medicine has caused Glaxo shares to decline 12 percent since then, cutting 9.94 billion pounds ($19.7 billion) from the company’s market value. Glaxo shares fell 18 pence, or 1.4 percent, to 1292 pence in London, the lowest price in two years.

“It’s fair to say that from early on there have always been a few events of cardiovascular nature,” Glaxo Chief Medical Officer Ron Krall said May 21.

Call for Research
As far back as April 1999, executives of SmithKline Beecham Plc, which a year later merged with GlaxoWellcome Plc to become GlaxoSmithKline Plc, told the FDA that Avandia caused “minimal” cardiovascular side effects and “mild to moderate” fluid buildup. Fluid in the lungs or bloodstream can increase the heart’s workload.

The agency cleared the drug for sale the next month. Some advisory committee members called for more research on potential complications.

In February 2001, after the drug was on the market, Glaxo agreed to an FDA request to change the drug’s prescribing label to warn doctors that Avandia, like other drugs in its class, can cause fluid retention.

Company sales representatives who knew the risks “denied their existence” three months later in oral presentations at the American Association of Clinical Endocrinologists’ meeting in San Antonio, Texas, FDA officials noted in a July 2001 letter to Glaxo.

FDA Criticism
The FDA told Glaxo in that letter that its marketers should stop denying or minimizing the increased risk of “heart failure or other cardiovascular adverse events” in patients taking the drug with insulin, according to the FDA’s Web site. The agency criticized Glaxo for continuing to “engage in false or misleading promotion of Avandia.”

Analysts at Citigroup Inc. and Morgan Stanley had noted possible cardiovascular side effects in notes to investors last year.

“The key issue in addition to at least equivalent efficacy of Avandia to metformin and glyburide is cardiovascular safety,” Citigroup analysts wrote in a Nov. 23 report.

The next month, as results of a large-scale, company-funded trial were published, Glaxo executives said the overall risk of death, heart attack and stroke with Avandia was similar to other diabetes medicines.

`We Can’t Deny’
Diabetes researcher Rury Holman of Oxford University in the U.K., an investigator in the $100 million company study, known as ADOPT, said in a Dec. 3 interview that the results would cause concern.

“These people are early diagnosis, they haven’t got complications,” Holman said. “The fact that we’re seeing these cardiovascular effects in them, we can’t deny that. The concern when these data come out is you’ve got relatively healthy patients and still there’s a little bit of a signal.”

Earlier this year, cardiologist Steven Nissen and co- researcher Kathy Wolski of the Cleveland Clinic found Glaxo’s own analysis of Avandia studies while scouring the company’s Web site. The two uncovered the analysis after failing to gain the company’s cooperation for their review, Nissen said in an interview May 23.

“I just built this piece by piece until I had enough,” Nissen said. “Then I stumble upon the company’s own meta analysis deeply buried on their Web site, and it shows the same thing. It was a eureka moment for sure.”

Glaxo Responds
Earlier this week, Glaxo began a campaign to challenge Nissen’s findings that helped its stock recover. Chris Viehbacher, the president of Glaxo’s U.S. pharmaceuticals unit, met with reporters May 30 to take exception to the report and the “sensationalizing” of it in media coverage. Krall wrote a May 30 letter to the U.K. medical journal The Lancet which the company said “clarifies the safety record of Avandia.”

Since 1999, the company and the FDA have monitored and updated Avandia’s label for adverse events and continue to do so, the company said today in an e-mailed statement.

“The totality of data provide clear evidence that Avandia has a comparable cardiovascular profile to other oral diabetes medicines and that these data are more scientifically rigorous and more clinically meaningful than the recently published meta analysis,” Glaxo said in the statement.

The company’s failure to place as much emphasis on Avandia’s risks as it placed on the drug’s benefits may hurt it because of possible legal liability, Morgan Stanley analysts led by Andrew Baum said May 21 in a note. Avandia is facing competition from newer treatments, and reports of a heart risk may hurt sales by as much as 50 percent, analysts estimate.

GlaxoSmithKline’s “robust defense of Avandia safety and their conduct comes with a high risk if evidence of poor disclosure subsequently emerges,” Baum wrote.

To contact the reporters on this story: Andrea Gerlin in London at agerlin@bloomberg.net Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

12 Responses to “Avandia negative data – “Why would you publicize it?” says JP Garnier”

  1. truthman30 Says:

    “Why would you publicize it?,” Glaxo Chief Executive Officer Jean-Pierre Garnier told reporters at the company’s annual meeting May 23 in London. “We don’t publicize every submission we make to the Food and Drug Administration.”

    Says it all really doesn’t it?….

  2. Matthew Holford Says:

    Well, in accordance with the rareified atmoshphere of Platonic discourse, for which this site really ought to be known, I think we should engage in a learned discussion, in our efforts to construct an appropriate response. It’s a thorny one, though, isn’t it?

    Should we agree that the drug in question makes a great deal of money for the Company? If we can agree on that, then one might choose to suppress information which undermined any (undeserved) reputation for safety, because that would presumably impact on sales. In which case, my friends, I would suggest that one would publish adverse findings if it was one’s motivation to undermined the profits of the Company, and to impact its share price, as a consequence.

    However, given that the Company is dedicated to the health and wellbeing of its customers (what with living longer and feeling better), should we agree that the previous explanation does not fully explain the position, because if it was the Company’s determination to safeguard and improve the health of its customers, then it would disclose details of adverse findings, in order first, to demonstrate its commitment to THE PRINCIPLE OF transparency (thanks to Krall, for that one); and second, to simultaneously demonstrate that commitment, by being transparent.

    Naturally, my learned friends, we are not in full ownership of the facts, if we can agree that, but I believe we may satisfy ourselves that, if one were a drug manufacturer, one would disclose information about a serious adverse event, in order to protect one’s customers from the consequences of that adverse event.

    Discuss.

    Matt

  3. truthman30 Says:

    Excellent Post Matt …

    Couldn’t agree more …

    I feel that it is at times like this, we must rejoice in the mantra of GSK which is “Do more , Feel Better, Live Longer”…

    Somehow i don’t think people who might have had heart attacks from using Avandia will be singing that from the hilltops anytime soon though….

  4. Matthew Holford Says:

    Bugger: “Do more…” that was the bit I forgot! And you’re right: that tagline is a really soft lob, if you’re struggling for a cheap laugh!

    In spite of everything we’ve uncovered, between us all, I’m still struggling to come to terms with the lack of action. I know why it is: the people who are dying appear to be regarded as dispensable, and not part of the club making the decisions, but you’d think that they’d have one decent neuroconnection between them. Mind you, if their synapses suddenly started firing differently, they’d probably go into meltdown!

    I feel very sorry for anybody who’s taken one of GSK’s drugs, and had something like this happen (I don’t even know who made my fluoxetine). It’s not just the stuff that happens that hurts, its the denial of responsibility. In fact, it’s not even that, it’s that nobody steps in to say enough’s enough. In fact, it’s not even that, it’s that nobody appears to give a shit.

    Anyway, speaking of meaningless, I’ve just been trying to deconstruct the etymology of “Avandia”. A = to in Latin/not in Greek when prefixing a word. Van = front part of an advancing group (short for vanguard). Dia = through/across. Complete bollox. “Not across the front part”. Shows how much they think about anything.

    Matt

  5. Matthew Holford Says:

    As an afterthought, I suspect that JP may well be steered away from the microphones, in future!

    Matt

  6. truthman30 Says:

    To be honest Matt, I seriously think that Drug Companies deliberately operate like this now and it has become the “norm”…

    If you think about it, why would they reveal the risks with their drugs at the beginning, the first few years of a new drug launch is paramount to the success of the brand. They know that by the time the truth comes out, they will have made billions in profits, and by the time the lawsuits start to come in, it can be years later again. And even in those cases, most can be very difficult to prove, with the lawsuits which actually do get anywhere, the payouts are minimal and don’t affect the companies profits in amny major way.

    I really think they measure the risk on investment and that this kind of thing has set a new standard of drug production. In other words, it is company policy to operate like this. And anyhow, they have gotten away with it before, with no affect on profits, so why not continue it…. ?

  7. truthman30 Says:

    Glaxo …

    The three P’s …

    “Profits come first, Physicians finish second by default, and Patients come last!”

    Quoted from the GSK Drug Rep Forum On Cafe Pharma …

    http://www.cafepharma.com/boards/showthread.php?t=208039

    http://www.cafepharma.com/boards/forumdisplay.php?f=26

  8. truthman30 Says:

    http://www.cafepharma.com/boards/showthread.php?t=207997

    Avandia Bribes today in the NYTimes

    nother reason our industry has gone to the dogs: Greed is what built this country and Glaxo had mastered it until now……

    Dr. Anne L. Peters, a diabetes expert who runs a clinic for Los Angeles County and is affiliated with the Keck School of Medicine at the University of Southern California, said that she had previously received money from Glaxo as a speaker on behalf of Avandia, but had resigned because she was worried about the drug’s risks.

    About five years ago, she said, she helped change the formulary — or list of preferred drugs — for Los Angeles County so that patients in her clinic would get prescriptions for Actos rather than Avandia.

    “The Avandia people, it was just so surprising, they asked me what I wanted to keep Avandia on the formulary,” Dr. Peters said, recounting events that occurred sometime in the 2000-to-2002 period. “They asked me, “What can we give you that will have you keep it on the formulary?’ ”

    Dr. Peters said that she asked the company to establish a database at the clinic that would track the outcomes of patients on both drugs.

    When she asked for the database, which would have cost several thousand dollars, she said, a company representative replied: “That’s all you want? Other doctors ask to go to the Caribbean.”

    Dr. Peters said that Glaxo representatives first asked her to write a proposal, then asked her to go to Philadelphia to meet with company officials before the database could be approved. She decided to purchase it herself.

    “They wanted to give me everything but approve my request,” said Dr. Peters, who has served as an adviser or consultant to Takeda and Eli Lilly. During a recent interview, Dr. Buse said that although he was outspoken in criticism of Avandia in the early days, he now argues that the drug should remain on the market until Glaxo completes a large clinical trial, which the company says will answer questions about Avandia’s cardiovascular risk.

  9. Matthew Holford Says:

    “To be honest Matt, I seriously think that Drug Companies deliberately operate like this now and it has become the “norm”…”

    Hypocrisy and fraud as a business model? Hmmm. I think I’ll see if I can piece together an argument to support that theory, because it sounds quite plausible to me. I’m not sure the thing’s limited to Big Pharma, though. My old employer was pretty hot to trot in both fields, as far as I can establish.

    Matt

  10. samah Treifi Says:

    I need to publish some press releases on you website

  11. samah Treifi Says:

    how can i publish a press releases

  12. admin Says:

    Samah – please go ahead


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