Posts tagged ‘Pfizer’
Dr. Scott Reuben has been sentenced to six months in federal prison for proving to be one of the most fraudulent players in an increasingly fraudulent pharmaceutical industry. While his behavior is nothing new one, arrests like this do not seem to come along often. I can only hope it’s a sign of things to come — but I won’t hold my breath. I’m left wondering if he was arrested for perpetrating fraud or for not being good enough to keep it hidden.
From The Day:
Dr. Scott S. Reuben, a prolific pain researcher at Bay State Medical Center in Springfield, Mass., who during a 12-year span is believed to have faked at least 21 studies, will also have to return more than $360,000 to drug firms, including Pfizer, that gave him money for research. Pfizer will receive more than $300,000 in the deal that Reuben reached with federal prosecutors as he pleaded guilty earlier this year to one count of healthcare fraud.
Other fines and penalties in the case will require Reuben to repay nearly half a million dollars to various parties.
His faked studies include among others, studies for the drugs Celebrex and Vioxx. The latter of course, was pulled from the market due to concerns about its safety. You may remember those “concerns” adding up to more than 25,000 deaths by the FDA’s estimate.
Purported studies published in well-regarded medical journals specializing in anesthesia have since been retracted…
Rueben’s studies had been seen as pioneering when they were published. His data had supported the use of two of Pfizer’s major products – Celebrex and Lyrica – in combination to treat certain types of post-operative pain.
Of course his studies were pioneering — they were made up. With some of his studies pulled and others remaining on the books, one has to wonder if any are legitimate or if some just haven’t proven to be frauds — yet. I would certainly not want to be on a drug that was shown to be safe by one of the most fraudulent drug researchers in pharmaceutical history. One also has to wonder how many other doctor have faked studies in the major medical journals — or are we supposed to think Reuben’s the only one?
Pfizer getting their money back doesn’t mean they’re blameless either. It seems likely that they were happy to keep paying him as long as he kept coming up with the right answers. Sadly, frauds in this arena seem to be overlooked all too often. I say sadly because millions of lives hang in the balance while their products are sold in staggering quantities based on the work of researchers who are often paid more for supporting a company’s interests than carrying out research with anything resembling actual integrity. As Jim Edward for BNET put forth in an informative article on the topic,
Pfizer wasn’t looking for research that simply broadened doctors’ knowledge of how Cox-2 painkillers work. It was almost certainly using that research to bolster its “operate for cash” promotion, in which pharmaceutical sales reps persuaded surgeons to write “protocols” for using Pfizer’s Bextra and Celebrex as post-operative painkillers instead of opioid drugs. Such uses were not approved by the FDA.
With all of the money these doctors are getting paid to study the safety and efficacy of drugs that they’re simultaneously paid to promote on the lecture circuit (read: pharma sales pitches as continued education), is a conflict of interest even in question?
Like all of the major pharmaceutical companies, Pfizer has a history of misconduct, corruption and deceipt but when is enough really enough? They were overdosing children on Geodon in clinical trials marked by almost every kind of failure and misstep. It’s okay though, they got…(gasp!)…a warning.
Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.
The FDA warned Pfizer that its trials of Geodon in children were improperly monitored, and that children got too much drug by mistake:
… dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.
…a Pfizer internal document dated October 3, 2007 and entitled “Safety Information on Affected Subjects” refers to the overdosing of an additional six pediatric subjects in study (b)(4) at two different sites…
The kids suffered from nervous tics and a loss of control of their limbs, among other symptoms. Pfizer said it conducts tests globally according to the highest ethical and scientific standards:
HIghest ethical and scientific standards? I would love to know what passes for standards at Pfizer because from where I’m sitting, it’s hard to recognize any. They’re treating children like guinea pigs — and poorly treated ones at that.
Of course the company responded in the industry’s typical own-up-to-it-and-say-you’re-trying fashion with a letter that reads like the kind we were made to write as schoolchildren about how we understood it was wrong to disrupt the class or make messes.
Pfizer recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA’s concerns. Many of the items cited by the FDA were first uncovered and reported to the FDA by Pfizer as far back as four years ago as part of our ongoing clinical trial monitoring and quality assurance processes. Since that time, Pfizer has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators.
Pfizer has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues with Pfizer clinical trials in the future.
It just sounds like more talk about writing up new policies of the type they’ve already proven to be capable of sticking to. I guess when it takes the FDA five years to get around to giving you a warning when you’re abusing children with drugs, the sense of urgency kind of goes out the window, doesn’t it?
If the dosing wasn’t enough, it would appear as though their application for Geodon use in children was “intentionally misleading regarding its cardiovascular effects.” On top of that they were accused by the DOJ of marketing off label (but then who doesn’t these days?) and stated in a DOJ statement:
The government alleges that Pfizer also promoted Geodon for use by unapproved patients, including pediatric and adolescent patients, and promoted Geodon for higher dosages than were approved by the FDA. This conduct included direct promotion by Pfizer sales representatives and promotion through the hiring of physicians, or “key opinion leaders”, to give promotional talks to other physicians about unapproved uses and dosages of Geodon. Specifically, these talks included encouraging doctors to prescribe the drug for children, and to prescribe the drug at substantially higher than approved dosages.
There is a lot of money in the sale of antipsychotics, particularly among children, a captive market that seldom has the option of saying no to the drugs. Pfizer pays a lot of money to doctors and other promotional outlets for one simple reason. They stand to make a lot more. They’re paying millions to make billions. Doctors selling other doctors on off label drugging and groups like NAMI promoting the notion to the patients for which they claim to advocate affords the company a kind of sales force that even the slickest of television and print ad campaigns can’t match.
One doctor was paid $4,000 a day to fly his private helicopter to meetings where he promoted Geodon off-label, according to a separate whistleblower suit, which Pfizer also settled.
And Pfizer allegedly gave more than $1.3 million in funds to the National Alliance for the Mentally Ill, a non-profit advocacy group, and hired the president of the organization as a paid speaker, according to another whistleblower suit. In an amazing coincidence, NAMI published a web page which advocated off-label use of Geodon in children.
So when is enough enough? if a company (really an industry) can lie about health risks, experiment on children, abandon ethical and scientific standards and engage in all manner of misconduct — what is too much? Why does it seem that all issues relating to pharmaceuticals and mental health seem to be relegated to smaller outlets of information and opinion put out by people who already have a position on one side or the other? Openly corrupt companies overdosing kids is not a special interest piece specific to mental health but a statement on our mistreatment of our nation’s youth regardless of the methods. I guess it’s easy to quell the outrage now that a warning from the FDA has set everything right again.
As some may have noticed, things come in waves around here. I’ve been very busy in recent weeks and I have not been able to post with the frequency I would like. I’m still paying attention and SB&F is not losing steam. I offer you two links that are very much worth following up on.
Pfizer: Too Big to Nail?: A giant among pharmaceutical companies, Pfizer has skirted the law in a big way on the basis of its size alone — and their friends in the FDA are happy to help. When they were found guilty of marketing a drug off label without regard for patient safety, they should have been convicted. but…
Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA’s judgment over which products are safe and effective. For that reason, “off-label” promotion is against the law….
But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.
Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence…
So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.
The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.
I don’t know how we’re supposed to think pharmaceutical companies are held to any measure of legal accountability when the FDA, whose function is to protect not just public interest but patient safety, puts the viability of its friends in industry first. On the basis of the “too big to nail” argument, it seems unlikely that our beloved drug makers will ever actually be treated as criminals no matter how criminal their actions. They’ll just pay their dues to the club in the form of relatively small cash settlements and carry on with business as usual.
Oregon Governor Vetoes Prescription Privileges for Psychologists: I recently posted about psychologists’ attempt to gain prescription privileges. Recently, Oregon Governor Ted Kulongoski vetoed the proposal in his state on the grounds that the shorter special session did not allow the time needed to thoroughly look into what was being voted upon. Given the impact such a change would inevitably have, it’s refreshing to see a politician take the slow and deliberate approach no matter how it ultimately ends up. Taking a decidedly different path than many states and our federal government, he decided against major changes decided in a short time with vague wording and too many loose ends. From Psych Central:
“I have a serious concern as to whether the special session in February provided opportunity for citizens and interested stakeholders to be adequately involved in the development of those proposed major policy changes,” Gov. Kulongoski of Oregon wrote in his veto letters.
Medical groups and even some psychologists — including Dr. John Grohol of Psych Central — opposed the bill. Gov. Kulongoski said such a change “requires more safeguards, further study and greater public input.”
And from the Oregon Politico:
Rem Nivens, spokesman for Governor Kulongoski, clarified that the Governor is supportive of the legislation which passed in February proposing a short, month long session in between regular sessions.
He added, however, that major policy changes, like the ones vetoed on Thursday, should wait to be brought up during a longer regular session. This will allow for the proper input from citizens and key players in the policy.
“The public give-and-take is critical to crafting and amending legislation by allowing all interested parties to be involved in the development of public policy,” Kulongoski stated. “I believe we must always be open and transparent when we are proposing changes to long established Oregon policy, especially in a short legislative session.”
The National Alliance on Mental Illness (NAMI) calls itself the “nation’s largest grassroots mental health organization.” If they are a grassroots organization, then the soil is tainted and the land bought and paid for — largely by pharmaceutical companies. Over half of their funding in the just the past five years has been in the form of pharma money. That’s several million dollars. Their list of major contributors reads like a who’s who of psych drug peddlers — all of whom have their own ethics problems lately, including everything from paying doctors to promote for them to lying about adverse clinical trials findings and illegally promoting the off label drugging of children.
The latest glimpse into the NAMI’s affair with pharma is the report that, in light of the fact the drug companies can’t directly market their product for off-label use, Pfizer paid NAMI hundreds of thousand of dollars in exchange for their promotion of Geodon, an atypical antipsychotic, for use on children and the elderly, for which there is no FDA approval and the dreaded black box warning in some cases. All of this is also in conflict with the group’s own professed policy against promoting drugs. When more than half of your money comes from drug manufacturers, you tend to keep it a bit less obvious.
”Drug manufacturers have developed relationships with front organizations – industry-funded grass-roots, consumer advocacy, research and educational organizations whose primary goal is to promote marketing, influence regulations or advance other industry interests,” according to the suit.
The Arlington, Va.-based National Alliance for the Mentally Ill… has received at least $1.3 million from Pfizer over the years, according to the suit.
What’s more, its former president, James McNulty, during his time as NAMI’s leader, “received thousands of dollars for regularly speaking on behalf of Pfizer and other drug makers,” the suit said. “McNulty’s relationship with Pfizer was particularly cozy,” the suit said, and the group’s Web site “goes so far as to promote the off-label use of Geodon in children and the elderly, as well as for long-term use in the treatment of bipolar disease.”
The promotion of Geodon goes against the group’s stated policy of not endorsing products, according to the suit. What’s more, the suit said, such uses of the drug have not been approved by the FDA, and the prescription of Geodon for dementia has received a black-box warning from the agency.
It may seem to some as though it is of little import but NAMI isn’t a just some group out to offer help and reduce stigma related to mental illness, although that is part of their claim. When government policy is enacted, when information is needed, when decisions are made about the treatment of people with mental health diagnoses, NAMI has a seat at the table — so much so that they refer to themselves as “the preeminent voice on Capitol Hill and in state houses across the country for the millions of Americans living with serious mental illness.” They are the loudest voice claiming to come from the corner of those diagnosed as mentally ill and often the only voice that is sought. They’ve presented themselves as an authority on mental illness and the buying public in this arena as with any other is desperately seeking an authority.
… the off-label marketing of Geodon was all about money. And it may have paid off: According to the suit, initial sales of Geodon eight years ago were a disappointing $150 million, leading the company to offer sales incentives to boost the drug to the $1 billion blockbuster category, which it reached last year for the first time – three years behind schedule.
”Pfizer has engaged in a deliberate pattern of false and misleading promotion,” the suit said. “Off-label promotion of Geodon … became ingrained in the sales force and Pfizer management.”
It is harmful enough when drug manufacturers are more about profits than actually offering tools for care. It’s unconscionable when doctors and so-called grassroots groups are doing it, all while claiming to be a voice for the mentally ill. Dangerous things happen when a cash fueled machine teams up with the smiling face of an organization banded together to speak for you — and over you.