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January 28, 2009

Pfizer’s Big Week: The Good, The Bad, And The Just Plain Ugly

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:02 am

A record-setting $2.3-billion settlement for off-label marketing of Bextra is buried in an earnings statement, and the entire shoddy affair put in the shade by a simultaneous, glittering announcement  of a $68-billion acquisition of Wyeth, which will make Pfizer the 4th largest corporation in America.

Big Pharma giant Pfizer has had quite a week keeping its spin doctors on a tightrope looking for ways to turn manure into marmalade trying to balance good news with bad.

Judging from most media accounts of events swirling around the company, the spinners have done an admirable job. And the way it looks from here, it all breaks down into the good, the bad, and the just plain ugly.

First, the good — well, the almost-good.

We always cheer when the black hats get strung up by the white hats — it’s Hollywood’s version of the American Way. A record-setting $2.3-billion settlement with the Justice Department for off-label marketing of its cox-2 painkillers Bextra and Celebrex is sort of like that. It would be better if someone actually got locked up in the hoosegow, or maybe got strung up for real. That would better make up for the thousands of drug-related injuries and alleged deaths.

The settlement follows agreements in principle last October to pay $745 million to settle personal injury lawsuits, $60 million for attorneys general in 33 states, and $89 million to resolve class actions, says a report in the Wall Street Journal — in total almost another $1 billion.

Next, the bad. It wouldn’t have happened without the good. But then, dad always said there’s going to be a flip side, and don’t let it spoil the good. We’re still trying, but sometimes it ain’t easy.

The massive federal settlement was the main factor in Pfizer’s Q4 earnings crashing 90 percent, and dividends slashed in half — not good for the economy, especially these days. Dividends among US companies are being cut at the fastest pace in at least 50 years, according to media reports, many from companies investors have been relying on to provide income during the recession.

Seven companies in the Standard & Poor’s 500 index have decreased their dividends, removing some $12 billion from shareholders’ pockets, and Pfizer is the latest blue-chip to do so. But in the case of Pfizer, it should give pause to investors who insist on betting on criminals.

But much worse, in some respects, is the acquisition of Wyeth Pharmaceuticals, which on the plus side will result in a leaner company, but only at the expense of close to 20,000 jobs, and the closing of at least five factories — that’s what we call the flip side.

Finally, the just plain ugly. On one hand, the media’s endless romance with the corporate ‘big deal’ — ignoring the real issues, the underlying nastiness in American business, and consigning it to the last paragraph, or to everlasting darkness — is just plain ugly.

The media is dazzled by dollars, by gazillionaire CEOs with the kinds of salaries and perks and golden parachutes and jets and helicopters and fabulous corporate getaways that would make Midas blush. One can only wonder what its reliance on advertising revenue has to do with its tender treatment of America’s corporate ghouls.

Meanwhile, corporate America’s increasing cleverness in burying its crimes, its dead, and its wounded in spin doctor trash, is just plain ugly. And here we are really targeting Big Pharma, because no other industry has such a life-or-death throttle-hold on the jugular of Americans, and no industry should be held to a higher standard.

The largest, most staggering settlement in history, $2.3 billion, for what could reasonably be called — albeit non-technically — criminal behavior, was announced in two buried, misleading sentences in a Pfizer earnings report and press release. And the media, in general, has so far ignored it, or at least its ramifications.

Yet the lives, health and welfare of almost everyone in the country is in their hands. And the pharmaceutical industry continues to bite those hands in spite of the obvious fact that those are the very hands that feed it. That is just plain ugly.

January 27, 2009

Planning A Visit To Your Doctor? Get Ready To Be “Primed”!

Filed under: Big Pharma, FDA — Rod Malcolm @ 12:22 pm

‘Priming the Pre-Visit Patient’ is the latest marketing idea presumably designed to push us all along the road towards Big Pharma’s dream of a pharmaceutically-controlled future society.

I don’t know what ‘Priming the Pre-Visit Patient’ is exactly, but I already don’t like it.

On Feb. 5, 2009, if one is so inclined, one can join a Webcast that reveals ‘Understanding and Priming the Pre-Visit Patient’ to a breathlessly-awaiting, brand-enslaved, drug-marketing world.

Here’s the blurb describing it. Try not to up-chuck while reading:

‘The point at which a patient plans and schedules a visit to their doctor represents a significant window of opportunity for promoting treatment options and maximizing the growth of specific brands. Experts in patient engagement and marketing from the pharmaceutical, agency and media fields discuss pharma’s role in priming the pre-visit patient for a more beneficial dialogue with their physician.’

Don’t you love ‘ . . . priming the pre-visit patient for a more beneficial dialogue with their physician’?

Beneficial for whom? The doctor or the patient? No way. For Big Pharma? Absolutely.

I don’t know how they plan to accomplish it, but ‘Priming the Pre-Visit Patient’ is just more brand-name brainwashing — like DTC, but on steroids, judging by the sound of it.

Just when we’re starting to have some success banning the ‘data mining’ of our prescribing habits, along comes this intrusion into our lives — more marketing manipulation of medical decision making, more pressure on physicians to prescribe this or that brand name drug — basically, more pharma marketing intrusion into the practice of medicine.

Oh where oh where is the FDA we once knew and respected and trusted? Maybe Obama’s new man at the agency, whoever that’s going to be, will take a long, hard look at pre-visit patient priming along with DTC and all the rest of Big Pharma’s unwelcome intrusions into our dialogs with our physicians.

January 22, 2009

Emory Lets Nemeroff Remain As Full Professor In Spite Of Evidence

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 2:18 pm

With restraints on grants and contracts for two years, psychiatrist Charles Nemeroff is being allowed to stay on as a full professor at Emory University, but his record suggests that Emory’s sanctions have not gone far enough.

Following a Senate investigation last year which found alleged conflicts of interest among academics who received payments from Big Pharma while receiving NIH research grants, psychiatrist Charles Nemeroff of Emory University must relinquish his 17-year post as department chief, but is being allowed to remain as a full professor.

Emory has also ruled that Nemeroff must follow restrictions on his outside activities, and cannot be included in any National Institutes of Health (NIH) or other grants or contracts as an investigator or in any other capacity for a period of ‘at least two years’.

Nemeroff, who raked in more than $2.8 million in ‘consulting’ fees from drug makers between 2000 and 2007, violated federal grant rules by not reporting at least $1.2 million of it to Emory as required under federal law. According to documents provided by a Congressional investigation led by Sen. Charles Grassley, Emory officials knew that Nemeroff failed to properly disclose payments, but did nothing about it.

The NIH has awarded Emory more than $251 million in funding this year — 61 percent of its total research funds from outside sponsors. But in the wake of the Nemeroff scandal, the NIH has frozen payments for a $9.3 million project on depression led by Nemeroff after completing only two of its proposed five years. The NIH has also levied new constrictions on grant approvals for Emory, demanding more thorough investigations on researchers’ outside activities and conflicts of interest.

With that kind of funding on the line and the NIH’s tough new stance, you get the idea why Emory is finally taking an interest in conflict-of-interest among its staff instead of turning a blind eye to corruption.

Nemeroff’s many critics say he collected millions of dollars in speaking and consulting fees from Big Pharma reviewing and promoting their drugs to the medical profession, both in print and through speaking engagements. Some question the validity of scientific trials he has overseen, because personal payments obviously can compromise science.

According to Ed Silverman at Pharmalot, Emory claims it could find no evidence that Nemeroff’s activities on behalf of Big Pharma affected clinical care for patients enrolled in clinical trials, and no evidence his activities biased scientific research. Nemeroff says his lectures were limited to general medical topics such as depression and bipolar disorder and not product-specific, a contention that Emory officially supports.

Alison Bass, a former Boston Globe medical reporter, and author of the excellent Big Pharma expose ‘Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial’, claims just the opposite is true.

In her blog about Emory letting Nemeroff ‘off the hook’, Bass states:

“Over the years, Nemeroff has most definitely given product-specific lectures on behalf of drug companies,” Bass writes. “As I note in Side Effects, Nemeroff spoke on behalf of Eli Lilly, the maker of Prozac, during the pivotal 1991 FDA hearing on concerns that Prozac increased the risk of sucidal thoughts and behaviors among patients taking the SSRI antidepressant. (At the time, Nemeroff had lucrative consulting arrangements with Eli Lilly and also owned stock in the Indianapolis-based drug company). As part of his presentation to the FDA, Nemeroff specifically talked about the available research on Prozac and other SSRI antidepressants (including Paxil) and went so far as to dismiss case reports then emerging about the suicidal risks of these drugs. According to people who attended that hearing, Nemeroff’s ‘elegant’ and very product-specific lecture that day helped convince the FDA advisory board to dismiss concerns about these drugs’ side effects. As a result, it took the federal agency another 13 years to put black box warnings about the suicidal risks on Prozac, Paxil and other antidepressants.”

One can only wonder how many hundreds or thousands of lives were lost or ruined during that 13 years that are directly attributable to Nemeroff’s pimping on behalf of Big Pharma.

For a good idea of just how far out (dare I say ‘crazy’?) Nemeroff is in his quest for cash from Big Pharma, the good doctor hired himself to write for a magazine he edited for a payment of several thousand dollars an article ‘celebrating’ the 5-year anniversary of Wyeth’s Effexor antidepressant. Ed Silverman reports on Nemeroff’s letter, and you can read the wack-o “Dear Me” letter itself.

January 16, 2009

Lilly’s $1.4-plus Billion Zyprexa Settlement Falls Short Of True Justice

It’s time the Justice Department started jailing criminal Big Pharma executives and send a stronger message to an industry long on cash but utterly devoid of ethics.

Who’s protecting Big Pharma from really paying for its crimes?

Admitting that its marketing of the antipsychotic Zyprexa was illegal in a civil and criminal settlement, Ely Lilly will pay nearly $1.42 billion in fines, including a $515-million criminal settlement, “the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution”, according to the Justice Department.

A CNN report says Lilly will pay up to $800 million in a civil settlement with the federal government and the states, and forfeit $100 million in assets for fines and penalties totaling $1.415 billion.

These hefty fines make it sound like the DOJ lowered the hammer on Lilly, right?

I’d have to say, Wrong.

Zyprexa sales topped $4.76 billion in just 2007 alone. That’s been going on for years with little change. And after announcing personal injury settlements of nearly $700 million in 2005, Lilly just raised the price and continued its off-label push.

The fines are far from what should be the results of an admitted criminal conspiracy that not only cost the health care system a billion dollars, but also sickened thousands of unsuspecting people, shortening their lives or outright killing them.

In any other industry, executive ringleaders of criminal actions are put on trial and receive massive personal fines and lengthy prison terms. Just swindling others out of money, with no loss of life or personal injury to others, routinely means jail time for crooked financial consultants.

The Eli Lilly execs who ran the Zyprexa scam should not only receive personal fines and jail time, they should be on trial for aggravated assault causing bodily harm, if not manslaughter, or even murder. And the same goes for all Big Pharma executives who have conspired to market drugs causing injury, illness and death.

But case after case involving drug-related injuries and deaths due to unethical marketing or withheld or doctored clinical test results are being treated in the courts like bloated multimillion-dollar speeding tickets, instead of rightly prosecuting them the same as we prosecute criminal reckless driving resulting in injury or death with jail time.

For example, the personal fines levied against three Purdue execs in 2007 for their role in misleading the public about the dangers of OxyContin was a tap on the wrist — chump change, and no jail time. One reckless driver killing one single person puts that driver in jail. Yet hundreds of deaths and thousands upon thousands of ruined lives lie in the wake of OxyContin.

So we have to ask: Who’s protecting Big Pharma?

It’s got to be all about the money. It always is.

In all the cases against Big Pharma, over the past two decades or more, none of the agencies — DOJ, FBI, SEC, FTC, etc. etc. — has ever publicly revealed the Big Pharma money trail, or even admitted trying to follow it.

To me, that’s a sure sign that Big Pharma millions are finding their way into the pockets of power brokers in Washington, the ones who pull the strings at the DOJ and all the other agencies mandated to protect Americans from criminals.

January 15, 2009

FDA Ignores Financial Conflicts During Trials, Study Finds

Filed under: Big Pharma, FDA — Rod Malcolm @ 8:11 am

Not only does the agency pay scant attention to conflicts of doctors conducting clinical drug and device trials, it says doing so to protect patients is “not worth the effort”.

The New York Times reports that the FDA “does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects.”

The story says that agency officials told an investigation by the Inspector General of the Department of Health and Human Services that “trying to protect patients from such conflicts was not worth the effort.”

The agency has required drug and device companies to disclose financial conflicts of doctors overseeing patient care in clinical trials since 1999. Companies are required to collect this information before the start of any trial and to consult with the FDA. to resolve serious conflicts. But the IG investigation found that the agency has done almost nothing to enforce the rules, or to use the information generated.

In fact, Karen Riley, an FDA spokeswoman, said the agency opposed reviewing doctors’ financial conflicts before trials because they represented just one possible source of bias.

A similar IG investigation at the National Institutes of Health last year found a parallel situation, where NIH does almost nothing to police financial conflicts of university professors who receive federal money. And NIH officials also said they don’t want to start doing so, in spite of the legal requirements to do so.

It seems to this observer that neither the FDA nor the NIH considers financial conflicts of interest a factor affecting the ultimate health and safety of the public. Yet in case after case over the past few years, at the federal level and in almost every state of the union, public officials are up in arms about the obvious biases caused by financial conflicts of interest.

We’re looking at yet another prime illustration of how our federal government, over the past decade or two, has abandoned its responsibilities and turned the FDA and NIH over to new owners — Big Pharma and the device makers.

There must have been a note on the FDA’s door one night back in the ‘90s saying: “Will the last person out please turn off the lights, and leave the key with Big Pharma.” And it appears that the FDA complied.

January 14, 2009

Momentum of Change Will Affect Big Pharma Throughout 2009

Filed under: Big Pharma, FDA — Rod Malcolm @ 8:37 am

Four key changes in the marketplace, government and finance during 2008 will have a profound impact on Big Pharma this year.

Industry expert Mark Senak, author of the widely regarded blog Eye On FDA, cites four key changes the occurred during 2008 that offer “immense possibilities for change” in the pharmaceutical market, and the way business is done, in the new year.

In his recent blog titled, What’s in Store for the Pharmaceutical Industry in the New Year, Senak describes the recent changes he’s seen coming, and details how these might play out over the next 12 months.

For example, there will very likely be:

  • A years-long moratorium on Direct-To-Consumer advertising
  • New regs allowing importation of drugs by consumers
  • Greater government leeway for negotiating Medicare Part D pricing
  • A big increase in demand for generic drugs because of the recession
  • Loss of market share for brand-name drugs that don’t fill unique roles
  • More use, and more creative use, of digital communications and the Internet
  • A strong continuation of “risk over benefit” as the driving force behind reform and pricing issues
  • Pressure from Congress for Big Pharma and device makers to provide timely adverse event information

The points above are only some of Senak’s predictions, and are presented here without the details he provides.

But as we look them over, they do seem somewhat encouraging from the viewpoint of a public consumer.

But what the new Obama administration brings to the table on this aspect of health care, and especially what impact that will have on the administration of the FDA, and how far any of these reforms go towards improving public benefit and safety, remain to be seen.

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