Posts tagged ‘Pharma’
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Purported studies published in well-regarded medical journals specializing in anesthesia have since been retracted…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?
Another Bnet link via Beyond Meds, an increasingly reliable pairing for getting me infuriated about the state of a pharmaceutical industry virtually devoid of ethics.
It was established years ago thatPaxil carries a risk of suicide in children and teens, butGlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan…
The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo…
Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.
To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.
About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.
When do we reach the limit? When is enough enough? For all the talk of evidence based practice and apparently wiping out the need to scientifically determine things like the chemical imbalance these drugs are sold to “correct”, how is it somehow not enough that real world evidence shows Paxil in particular and drugs like it have terrible outcomes in a lot of people and markedly more so in children? On top of that we have the studies showing that the only effects SSRIs are known to have in appreciably greater amounts than placebo are the negative effects. The kids have already been guinea pigs long enough for use to know the results are not good and certainly not controllable.
It’s gotten to the point that when you see a child in the news that kills himself strangely young and seemingly out of nowhere or shoots his classmates or kills his parents, you can all but assume that child is on antidepressants. Those are the increasingly predictable behaviors that have earned this class of drugs their little black box. We need to realize that we are putting children on mind altering drugs and unless we know precisely how they work, we have no say over how these forming minds will be altered — here or in Japan.
Gianna Kali’s always informative and often pharma-critical blog, Beyond Meds was up for a Dosie — a new award “created to find the best examples of social media in pharma and healthcare.” Out of the 550 nominees, not surprisingly, blogs critical of the pharmaceutical industry and the accepted current standard of health care did not figure largely in the competition. Gianna cut through the pack though and made it to the finals — a feat unto itself. While she didn’t win, it has to be said — even if it sounds like a variation an all too familiar cliche — that when you are ever more informed and informing, nobody loses. So, congratulations to Gianna for a successful blog, for sticking to your guns and for toughing out a very difficult and ongoing recovery.
In an entry on her blog, written to be posted in the event that she won (but worth posting anyway so I’m glad she did), Gianna loses none of the bite that makes Beyond Meds worth checking out and, like any gracious recipient would do, she offered a thank you to the those that helped her get to where she is today (emphasis mine).
I’d like to personally name the two drug companies that are most guilty of my own physical demise, though all the psychotropic drugs are potentially nasty and debilitating on them and in some cases especially in withdrawal.
Lamictal and Klonopin as far as I can tell worked together synergistically to make me as sick as I am right now. So that’s GlaxoSmithKline and Roche who are most responsible for my iatrogenisis.
Lamictal acts on glutamate and Klonopin (as all benzos) acts on GABA. Both these drugs have widely unrecognized withdrawal syndromes. For information on benzo issues see here. For Lamictal problems here.
The GABA/glutamate system doesn’t just regulate mood. It regulates muscle movements, digestion, and sex — anything that involves anything communicating with anything anywhere in your body. When the drugs are removed after many years all hell breaks loose and is experienced by the whole body and mind. Thanks GSK and Roche for the loss of several years of my life.
Never missing an opportunity to raise the important questions, Gianna sums up what many outside of the accepted mental health paradigm are asking every day in one way or another — questions that are certainly fundamental to Spit, Bristle and Fury. It would have been awesome to see these things brought up in the faces of the pharma marketing circle directly but what she does is vital to a movement to question the paradigm and she’s not just preaching to the choir. Ask the questions, seek the answers and engage in the discussion
And what is mental illness, anyway? Does anyone deserve to be the arbiter of normalcy? Why does Western psychiatry get to limit the parameters of human experience, oftentimes through coercion, based on an incomplete and flawed science of the mind and brain? And, more tellingly, are our tactics for dealing with troubled human beings more or less compassionate using chemical restraint? Or, have we as a nation abandoned the obvious violence of the lobotomy for the secretive and bloodless path of the neurotoxic pill? What are the consequences for humanity as this paradigm of care is exported to the rest of the world?
In another case of pharmaceutical giants taking part in what has become a convoluted pay-to-promote plan, AstraZeneca is set to pay a $520 million settlement as the result of a federal investigation revolving around their off label marketing of Seroquel. That sounds like a lot of money until you realize they made nearly 5 billion off of the drug in 2009 alone. That makes the settlement look a lot more like paying a toll than a hefty fine and still raises the question, When (if ever) will convictions start coming down?
From the NY Times:
“AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,”Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners.
Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment.
“It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation,” Mr. Engelmann said.
If companies’ sidestepping safety measures and paying doctors to disregard patient safety is going to continue to be treated not as a crime but an indiscretion, there is little hope for a turnaround in any foreseeable future. It’s a bad step made worse by the fact that they’ve targeted some of the most at-risk and vulnerable among us. Children, elderly, veterans and prisoners are all left with little choice but to take the drugs they’re given whether the perceived need is determined by medical inquiry or financial gain on the part of the doctor.
Of course it’s in the company’s best interests to deny the allegations and pay the toll. The alternative, in theory and on paper, is to go down the road of criminal litigation. Patient safety be damned, there’s money to be made and if a conviction resulting from “protracted litigation” can exclude companies from government programs like Medicaid, then the best option for them will always be to pay these small settlements.
As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. The drugs have caused rapid weight gain in children, and side effects including deaths have prompted warnings against giving the drugs to elderly patients for dementia.
According to company e-mail messages unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study that showed Seroquel users gained 11 pounds a year, while publicizing a study that asserted users lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on unfavorable studies.
Warnings and small fines are not going to save lives or turn the tide of corruption in marketing and medicine, they will only serve as a payment of a toll and an acknowledgement of roles without consequence. If their actions are criminal and dangerous — and they clearly are — then they should be treated as such. Maybe we can start with actually prosecuting for their off label marketing and doctor kickbacks — or better yet, a few hundred thousand counts of reckless endangerment.
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.”