The life and death of a celebrity lawyer

I don’t know anything about Prozac and alcohol – however, I do know about Seroxat and the way that it can actually make you crave more and more booze. Couple this with the inhibition that comes with SSRI treatment and you’ve got a recipe for real disaster:

On the evening of Tuesday 6 May, Mark Saunders should have been having dinner with the television presenter Chris Tarrant, the latest high-profile client for whom the high-flying barrister had handled a divorce case.

Instead the Oxford law graduate was holed up in his £2.2m townhouse, in a five-hour armed siege that would end in his death.

Asked the question as to whether the police were correct to open fire on Saunders, the inquest jury yesterday answered yes. The unanswered question was what had made Mark Saunders, a 32-year-old family law barrister earning about £500,000 a year, act the way he did?

It seems Mark Saunders had a longstanding drink problem which he had been trying to control for a number of years. According to his wife “What Mark wanted to do was control the drinking, to be able to be a social drinker. There were occasions, probably every three months or so, when it went wrong.” She said that he would be ashamed at having lapsed and would to avoid her for a few hours, then send an apologetic text. Eventually he was prescribed Prozac to “even out his moods”, but she had no idea that he had begun to use cocaine heavily.

I can’t help but wonder why a doctor would prescribe an SSRI such as Prozac to a man who was already drinking heavily… in my experience with another SSSRI, Seroxat, that would be like pouring petrol on a fire.

Add in cocaine, coupled with a craving for more alcohol and an extreme lack of inhibition from the SSRI treatment and you have a suicide just waiting to happen and I think there can be no question Mark Saunders committed suicide.

The full story is here.

Eli Lilley – a criminal corporation that “…deeply regrets the past actions…”

I’ve followed the Zyprexa affair since the inception of this blog – it’s a scandalous example of all that’s wrong with big pharma today. Zyprexa is an unsafe drug that was illegally marketed in a very aggressive manner by Eli Lilley.

The only reason Lilley deeply regrets its past actions is because it got caught.

Nothing will change – the company will still market its dangerous drugs in illegal ways. There are ptofits to be made after all.

This from Philip Dawdy at Furious Seasons:

Eli Lilly Formally Pleads Guilty, Apologies To Investors, Ignores Victims

News is out that Eli Lilly today formally entered a guilty plea in court to criminal misdemeanor charges related to illegal off-label marketing of Zyprexa for dementia, a condition for which the diabetes-inducing atypical antipsychotic is not approved. The plea comes as part of a settlement Lilly reached earlier this month with federal prosecutors in Pennsylvania, wherein the Indianapolis-based drug maker also agreed to pay the feds and about 30 states $1.42 billion. So far, Lilly is on the hook for $2.7 billion in payouts over its nasty little mood pill and, as I noted earlier this week, the company could be forced to kick down another $4 billion to settle remaining states and class action lawsuits. Wouldn’t Col. Lilly be proud?

Hell, things got so messed up around Zyprexa that the company was outed by its own employees.

Two thoughts: the company is getting off cheap–Zyprexa has killed more than 3,400 people and injured many thousands more. Second, I can now refer to Lilly from here on out as a criminal corporation or use the adjective criminal in almost any way I want in referring to the company. So can you, and I encourage you to do so. Perhaps it’s time to get some T-shirts printed up. I wonder what size the CEO wears.

Meanwhile, Bloomberg reports that a Lilly executive yesterday apologized to investors in an analyst conference call (via BNET Pharma Blog):

“‘The company deeply regrets the past actions covered by the plea,’ said Phil Johnson, executive director of investor relations, in a call to investors.”

Two thoughts for Phil: you are apologizing to the wrong people. You should be apologizing to the many thousands of people your company’s drug has killed and maimed due to your company’s strategy of lying about how Zyprexa should be used in order to keep the company afloat when Prozac went off-patent in 2001. You should also apologize to the taxpayers everywhere who picked up much of the tab for your company’s rotten drug through Medicaid and Medicare. Anytime you criminals want to issue an apology to the public, you know where to find us. We’re the ones who aren’t on the analyst calls.

Two, you are a couple of letters short of a pretty decent first name.

Zyprexa – Lilly’s criminal drug marketing policies finally admitted

In March 2007, I wondered “how does a drug such as Zyprexa, that was approved for the treatment of adults with schizophrenia, and a few years later, was approved for short-term treatment of adults with manic episodes associated with bipolar disorder, become such a HUGE selling medicine?

“Despite its extremely limited original approved uses, Zyprexa has gone on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.”

Well, finally we know how they did it – they simply broke the law

This from Phil Dawdy at Furious Seasons:

News is out this morning (15 January) that, as expected, Eli Lilly has settled claims against it by the feds and numerous states for illegal off-label marketing of its antipsychotic Zyprexa. The company also pleaded guilty to a criminal misdemeanor charge of violating the Food, Drug and Cosmetic Act by promoting Zyprexa as a dementia treatment. The total settlement comes to $1.42 billion, bringing the company’s total Zyprexa settlements to date to about $2.7 billion. With more to come. Ten states have sued Lilly separately.

The settlement only covers off-label marketing of the drug for dementia. So what the hell happened to charges relating to the company’s lies about the safety of its drug in on-label uses such as schizophrenia and bipolar disorder? I think the feds and the states walked away from this too easily because the company, which I can now safely dub “criminal,” lied about the fact that its drug caused diabetes in all manner of patient populations. Surely, that’s worth something to the feds and the states.

Lilly has issued a statement:

“‘We deeply regret the past actions covered by the misdemeanor plea,’ said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly. ‘At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct.'”

Uh huh, just like with Prozac.

Two points come to mind about this story – first, although Lilley have paid out a huge amount – $3.12 billion in fines, they  still have made money with Zyprexa, such are the levels of sales their illegal marketing achieved.

Second – they broke the law which they admit – and in all probability the company has been directly responsible for the deaths of patients who took Zyprexa because of this illegal marketing.

And they’ve got away with it.

To find out more, just type Zyprexa into the search box on the left.

Lilly & Zyprexa – Glaxo & Seroxat?

I notice that Phil Dawdy at Furious Seasons has an update on the Zyprexa story. I’ve written about Zyprexa before but Phil is the Daddy on this one.

In March 2007, I wondered “how does a drug such as Zyprexa, that was approved for the treatment of adults with schizophrenia, and a few years later, was approved for short-term treatment of adults with manic episodes associated with bipolar disorder, become such a HUGE selling medicine?

“Despite its extremely limited original approved uses, Zyprexa has gone on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.”

This from Furious Seasons:

Late last week, US District Court Judge Jack Weinstein shot off his mouth in an opinion he filed in the midst of a merry-goround of opinions being filed as various Zyprexa cases under his purview are shaped up to march toward trial or settlement. Recently, Weinstein pressed Eli Lilly to settle all outstanding Zyprexa claims and various estimates put that figure at over $7 billion. Even at a payout of $7 billion, Lilly will be ahead on the deal. [Lilly has already settled about $1.3 billion in claims over its handling of Zyprexa].

Anyway, the judge let the FDA have it right in the kisser over Zyprexa, which, as most of you know, has been linked to thousands of cases of diabetes, hyperglycemia, massive weight gain, deaths and other problems:

“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”

Weinstein’s opinion is well-supported by the facts and he had more to say about the FDA in his opinion, which you can read  here (pdf file). As he notes elsewhere in the opinion, the drug regulators in other countries were not fooled by Lilly’s various smokescreens, but the FDA was.

He also went after Lilly:

“Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation….Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO.” [RICO is the federal Racketeer Influenced and Corrupt Organizations statute that was designed to prosecute various mafia families. That acronym coming out of the judge’s pen should have Lilly running for its settlement checkbook].

What strikes me about the the Judge’s opinion in this matter is that it could so easily have been written about Glaxo and Seroxat:

“… lack of transparency, failure to warn, and deceptive or illegal marketing practices… exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers… violation of obligations of transparency… deliberate encouragement of off-label use…”

And in the same way that the FDA has “failed consumers”, so in the UK we see the MHRA has done the same.

Eli Lilly trying to dodge the Zyprexa bullet… “we pay up – you shut up”

Despite talking tough like all drug makers when faced with court action, it looks like Eli Lilly don’t really want to defend themselves in court.

Drug companies have so much money that they buy themselves out of trouble each and every time and then enforce confidentiality agreements to keep the details of the cases out of the public eye.

It’s very much a case of the drug companies taking the line “we pay up – you shut up”.

A few days ago we learned that Lilly had settled another 900 personal-injury claims against its antipscyhotic drug Zyprexa, including five set to go to court next month, thus avoiding what would have been the first trial in the U.S. The Indianapolis drug maker confirmed the settlement Wednesday but declined to reveal the amount. With the latest agreements, Lilly has settled more than 25,000 claims, leaving about 1,100 unsettled. Many of the plaintiffs have claimed Lilly underplayed the drug’s side effects, including weight gain and elevated blood sugar. Lilly has set aside $1.2 billion to pay claims.

Now Alex Berenson from The New York Times brings us this story:

Lilly in Settlement Talks With U.S.

Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments see Drug Files Show Maker Promoted Unapproved Use (December 18, 2006).

If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines.

Several people involved in the investigation confirmed the settlement discussions. They insisted on anonymity because they have not been authorized to talk about the negotiations.

Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed.

Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines any uses not formally approved by the Food and Drug Administration.

Lilly may also plead guilty to a misdemeanor criminal charge as part of the agreement, the people involved with the investigation said. But the company would be allowed to keep selling Zyprexa to Medicare and Medicaid, the government programs that are the biggest customers for the drug. Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States.

Lilly would neither confirm nor deny the settlement talks.

“We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information,” Lilly said in a statement Wednesday afternoon. “As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so.”

Lilly also said that it had always followed state and federal laws when promoting Zyprexa.

The Lilly fine would be distributed among federal and state governments, which spend about $1.5 billion on Zyprexa each year through Medicare and Medicaid.

The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.

Prescriptions for Zyprexa have skidded since 2003 over concerns about those side effects. But the drug continues to be widely used, especially among severely mentally ill patients. Many psychiatrists say that it works better than other medicines at calming patients who are psychotic and hallucinating. About four million Zyprexa prescriptions were written in the United States last year.

Federal prosecutors in Philadelphia are leading the settlement talks for the government, in consultation with the Department of Justice headquarters in Washington. State attorneys general’s offices are also involved. Lawyers at Pepper Hamilton, a firm based in Philadelphia, and Sidley Austin, a firm based in Chicago, are negotiating for Lilly.

Nina Gussack, who is representing Lilly at Pepper Hamilton, said she could not comment on the case. Joseph Trautwein, an assistant United States attorney in the Eastern District of Pennsylvania, also declined to comment.

While a settlement has not been concluded and the negotiations could collapse, both sides want to reach an agreement, according to the people involved in the investigation. Besides the escalating pressure of the federal criminal inquiry, Lilly faces a civil trial scheduled for March in Anchorage, Alaska, in a lawsuit brought by the state of Alaska to recover money the state has spent on Zyprexa prescriptions. A loss in that lawsuit would damage Lilly’s bargaining position in the Philadelphia talks.

While expensive for Lilly, the settlement would end a four-year federal investigation and remove a cloud over Zyprexa. While Zyprexa prescriptions are falling, its overall dollar volume of sales is rising because Lilly has raised Zyprexa’s price about 40 percent since 2003.

Federal prosecutors have been investigating Lilly for its marketing of Zyprexa since 2004, and state attorneys general since 2005. The people involved in the investigations said the inquiries gained momentum after December 2006, when The New York Times published articles describing Lilly’s multiyear efforts to play down Zyprexa’s side effects and to promote the drug for conditions other than schizophrenia and severe bipolar disorder — a practice called off-label marketing.

Internal Lilly marketing documents and e-mail messages showed that Lilly wanted to convince doctors to prescribe Zyprexa for patients with age-related dementia or relatively mild bipolar disorder.

In one document, an unidentified Lilly marketing executive wrote that primary care doctors “do treat dementia” but leave schizophrenia and bipolar disorder to psychiatrists. As a result, “dementia should be first message” to primary-care doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically. Later, the same document says that some primary care doctors “might prescribe outside of label.”

In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

The documents were under federal court seal when The Times published the articles, and Judge Jack B. Weinstein of Federal District Court in Brooklyn rebuked The Times for publishing them.

The settlement negotiations in Philadelphia began several months ago, according to the people involved in the investigation.

Last fall, the two sides were close to a deal in which Lilly would have paid less than $1 billion to settle the case, which at the time consisted only of a civil complaint.

Then Justice Department lawyers in Washington pressed for a grand jury investigation to examine whether Lilly should be charged criminally for its promotional activities, according to the people involved in the negotiations. A few days ago, facing the possibility of both civil and criminal charges, Lilly opened new discussions with the prosecutors in Philadelphia.

If you want to find out more about this entire story, I suggest you type Zyprexa into the search box on the left hand side of this page.

Memory Hole 30 October – Scientific Misconduct

Yet another very interesting Memory Hole from Dr Blumsohn here.

On 30 October 1999 an important, worrying and predictive article by Sarah Boseley appeared in the Guardian.

This was about open, honest and properly represented science versus quackery. The problems were and are obvious.

The subject of the article was Prozac, Eli Lilly’s new ‘wonder’ drug.

You can read the whole article (and many, many others) here at Dr Aubrey Blumsohn’s Scientific Misconduct (never before has a blog been so aptly named).

Here are some snippets:

Since the launch of Prozac there has been a spate of disturbing accounts of violence and suicide committed by people prescribed the drug. Victims and families of killers have sued Eli Lilly but no cases had reached a verdict because Lilly settled out of court.

However in 1999 for the first time, Lilly came up against a family in the US who would not settle. The Forsyths wanted a hearing. Internal documents belonging to Lilly were produced in court, and these “showed that Lilly knew as long as 20 years ago that Prozac can produce in some people a strange, agitated state of mind that can trigger in them an unstoppable urge to commit suicide or murder”.

Lilly’s own internal documents show it was identified as early as 1978. On August 2 of that year, when only three trials were under way, minutes of a meeting of the Fluoxetine (Prozac) Project Team run thus: “There have been a fairly large number of reports of adverse reactions… Another depressed patient developed psychosis… Akathisia and restlessness were reported in some patients.” A similar meeting 10 days earlier had noted that “some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off [the] drug.”

The minutes further state that “in future studies the use of benzodiazepines to control the agitation will be permitted”. So, from that point on, Lilly’s trial subjects would be put on tranquillisers to get them over the akathisia experienced by some in the early days on the drug. Yet once Prozac was on the market, there was no warning to doctors that such action might be necessary.

Those who developed akathisia or who had any suicidal tendencies were excluded from the trial data on the basis that they would otherwise obscure the results of the drug’s success in treating depression. Yet the German licensing authority, the Bundes Gesundheit Amt (BGA), on scrutinising the results, expressed concerns about the drug’s safety. On May 25, 1984, according to Lilly’s internal documents, a letter from the BGA stated: “During the treatment with the preparation [Prozac], 16 suicide attempts were made, two of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation [Prozac].”

During the licensing process in the US, however, Lilly did not tell the Food and Drugs Administration (FDA) of the German concerns. Some of Lilly’s own scientists had reservations about this.

One of them, John Heiligenstein, wrote in an internal memo on September 14, 1990: “We feel caution should be exercised in a statement that ‘suicidality and hostile acts in patients taking Prozac reflect the patient’s disorder and not a causal relationship to Prozac’.

A memo from Thompson ran: “I hope Patrick [probably a Lilly employee, but not identified fully in the memo] realises that Lilly can go down the tubes if we lose Prozac, and just one event in the UK can cost us that.”

A memo from the German office to Lilly’s US headquarters in that November indicates that Lilly was keen to root out the word “suicide” altogether from its database record of side-effects experienced by patients on the drug: Claude Bouchy and Hans Weber in Germany were alarmed by suggestions from their US superiors that, when GPs reported a suicide attempt on Prozac to them, they should record it as “overdose” (even though it is not possible to kill yourself by overdosing on Prozac), and that a GP’s report of “suicidal ideation” should be recorded as “depression” – “Hans has medical problems with these directions and I have great concerns about it,” runs a memo from Bouchy to Thompson. “I do not think I could explain to the BGA, to a judge, to a reporter or even to my family why we would do this, especially on the sensitive issue of suicide and suicide ideation.”

Something had to be done. Lilly finally agreed to undertake the study suggested by the FDA, and look at the suicide rate among UK patients on Prozac, but it didn’t. Instead, the company put together a “meta-analysis”. Lilly’s own scientists, led by Charles Beasley, did the work.

Beasley’s study was published in the British Medical Journal in 1991. It had “the appearance of scientific rigour”, says Dr Healy, but it is clear, he says, in the light of the documents that emerged in the Forsyth case, that the so-called meta-analysis had included only 3,065 patients out of around 27,000 involved in the trials and that it had also included data that the FDA had rejected during licensing. Among those excluded from Lilly’s study were the 5% of patients who had shown akathisia-like symptoms during the clinical trials and had dropped out, and also the 13 or 15 suicides. Nor was there any mention of the fact that a considerable number of patients had been put on benzodiazepines to suppress the very problem that Lilly was claiming did not occur.

Recapturing the vision

Pharmaceutical firms need to make some drastic changes to the way they do business if they are to regain the public’s trust and must be seen to be more interested in medicines than market share to avoid even more damage to their image, a leading industry observer has told PharmaTimes World News.

Peter Claude, a USA-based partner at PricewaterhouseCoopers pharmaceutical and life sciences advisory services group, was speaking as the firm published a report, Recapturing the Vision which highlights the significant differences between the public’s view of pharmaceutical companies and the industry’s self perception.

Mr Claude said that “it is difficult to comprehend how an industry that has saved so many lives should be held in such low public esteem.”

At present, he told PharmaTimes WorldNews, “no-one is listening to them (the drugmakers) and no-one wants to listen to them,” which means that the industry has to change the dynamic of its communication, especially at a time when the sector is under such pressure from governments and a fairly hostile media.

However, I have to say the problem is not about “view” and “self perception” – Peter Claude is wide of the mark… the problem is about the reality that the pharmaceutical companies that are all too happy to create markets for drugs that they know to be unsafe and they are putting their wealth before patients’ health.

The age of the truly innovative blockbuster drug is over – Big Pharma knows this and so continues to market sub standard products to the public. This is the reason why we have seen marketing and advertising spend leap ahead of (by two to three times) the R&D spend at every major drug maker in the world.

This simple fact shows where Big Pharma’s priorities lie – science and discovery have taken a back seat and the salesmen are driving.

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