Posts tagged ‘FDA’

FDA May Require Testing of Electroconvulsive “Therapy” Devices

You may remember a couple of posts I made last year at this time about the importance of speaking up when the FDA opened itself up to comments on the issue of reclassifying the as yet untested ECT (shock treatment) machines from a class III to a class II. The situation was simple — in all the years the machines have been in use, the industry has never had to prove that they are either safe or effective. For decades people have been having their frontal lobes assaulted by electricity in varying amounts from just plain dangerous to thoroughly destructive on machines with no standard of testing to ensure that they’re working as designed, much less designed to address any established clinical use at all. This is not only frightening but a terrible insult to the rights and safety of the approximately 100,000 people who face ECT each year in the US (by choice or force) and only serves those profiting from the shock industry. In essence, the hundreds of thousands of people who have undergone this so-called treatment are the experiment — the living test.

Well, the good news is that it seems that the FDA’s protection of the shock industry may be coming to an end…

Peter Breggin, MD for the Huffington Post:

Friday afternoon, January 28, 2011: The FDA’s panel for electroconvulsive therapy (ECT) voted to place ECT machines in Category III for all but one indication. If the FDA accepts the panel’s recommendation, the agency will require testing for all uses except “catatonia” which was recommended for Category II, requiring less stringent testing.

A tiebreaker by the chair was needed to propose putting ECT machines into Category III for depression. Given acute trauma caused by the treatment and the evidence for long-term memory and cognitive problems, it reflects poorly on the panel that the vote was so close.

Indeed. Despite the polarized response to the matter from proponents and opponents of giving ECT a pass, each side claiming history has proven their point, the fact of the matter is that the FDA is supposed to be ensuring our expectation of some level of safety. If an industry is unwilling or unable (or in this case both) to prove its product safe and effective given the established (and frankly, lax) channels, then that product has no business being passed off as a reasonable course of action in our nation’s hospitals. This shouldn’t have come off as a vote on ECT’s supposed merits but on its decades-long exemption from the system — and that shouldn’t be a close vote at all.

It’s a little early to cry victory as it remains to be seen whether the FDA will follow the panel’s recommendation, what result that will actually have and how much the overlapping psychiatric and shock industries will play off of the catatonia exemption.

If the diagnosis of catatonia is given this loophole, we will see more and more people diagnosed with this disorder…It’s similar to what happened to children: massively increasing the diagnosis of bipolar disorder to justify giving them adult mood stabilizers and antipsychotic drugs.

Unfortunately, the FDA is already waffling about whether or not it will in fact require the usual testing for Category III devices. In response to questions at the hearing, the agency staff said it was not certain whether a Category III designation for ECT would require the same rigorous testing routinely carried out for safety and efficacy. No one on the panel seemed to think the treatment should be phased out until safety and efficacy were proven.

Psychiatric reform moves ahead a step at a time, falters, and hopefully moves ahead again. The classification of ECT into Category III for most conditions, which at this point is only a recommendation, is a step forward and a somewhat positive sign to those of us who have called for this for decades. We hope the FDA will uphold its obligation to the public to thoroughly test such a dangerous device for safety and efficacy.

Since the psychiatric and shock industries have essentially shaken off the burden of responsibility for the safety of the consumer (certainly at the industry level the term is more fitting than patient) and the FDA is apparently questioning its convictions about the protection of the public, the burden rests on the people. As neither of those entities are wholeheartedly committed to moving forward of their own accord to ensure the safety and the efficacy of products on the market and ECT cannot prove itself under any honest scrutiny, the burden then falls on the people to pressure them toward forward momentum and to keep the scrutiny honest…but then, has there ever been a time when that wasn’t the case?

January 31, 2011 at 11:01 am 6 comments

Doctor Gets Prison Sentence for Faked Studies

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?

June 26, 2010 at 8:46 pm 1 comment

Cross a Line, Pay a Toll

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.

April 28, 2010 at 9:26 am 2 comments

Pfizer Overdosing Kids in Trials (Now Act Surprised)

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.

From Bnet:

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.

April 23, 2010 at 9:21 am

A Two Link Mini Roundup

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…

From CNN:

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.”

April 11, 2010 at 10:55 am

A Senseless Passing, Reckless Drugging and a Strongly Worded Letter

I don’t have the time or energy to really delve into these intertwining stories so I’m just touching on them and providing links but I do think we should be paying attention to what is allowed to pass for care in this country and what is allowed to pass for accountability.

Florida has a terrible track record, pumping its youth and especially its children in foster care, full of pyschotropic drugs. Foster children in Florida are drugged about three times as much as children outside of the system. These drugs have  serious negative effects on developing minds and bodies and one of those effects is suicidal ideation. With that many kids drugged down and such extreme responses, it’s painfully obvious that many of those children are going to suffer terrible outcomes.

This was never more true than in the heart breaking story of Gabriel Myers, a child just seven years old who committed suicide by hanging while on a cocktail of psychotropic drugs including Seroquel. Seven years old. Suicide at that age is unnatural. A child that age taking his own life has been failed by somebody — maybe everybody. It took a long time in my mind to get to even thinking about what this says about broken systems, medication, responsibility and social failure — all I could think about was what a terribly sad, troubled and short life Gabriel had.

Florida’s response? From a CBS News article that does go on to present some critical views of the use of psych drugs in children:

The apparent suicide of 7-year-old boy Gabriel Myers, who was taking several psychiatric medications, has led to the introduction of a bill in the Florida legislature, which would assure that powerful mental health drugs dispensed to Florida foster care children would be more closely monitored…

The bill requires caregivers and doctors to report any adverse side effects, which DCF must document.

The bill also requires children to have a mental health treatment plan that includes counseling for children prescribed such drugs.

Monitoring? We need more than paperwork. Keeping track of your failures and an immediate reversal of your direction are two different things. Gabriel’s prescribing psychiatrist, Sohail Punjwani, is tied to a string of kids drugged down on powerful psychotropics and having horrible negative effects — facing everything from sedation and dizziness to hallucinations, suicidal urges and death either at their own hands or from the drugs directly and while he’s not the only one, he’s certainly at the center of the situation. It’s okay though. He got a strongly worded letter: From the Miami Herald:

A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.

In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.

A strongly worded letter? Strongly worded letters are written in response to bad stays in hotels not children dying at the hands of their reckless doctor. Surely, showing a complete disregard for the safety of your youngest patients warrants more than a letter. But then, it seems disregard for patient safety is just the tip of a particularly damaging iceberg. It would appear as though Punjwani, so far without interference from any overseeing agency, may have been using foster children in clinical trials. If that’s the case, the problem is systemic.

If experimenting on kids is the lowest of the low, I don’t even know what to say about hand selecting discarded or displaced children for a pseudo-science project. It is a clear use of a person’s social viability to define them as candidates for clinical trials.  You will never see a news report of senators’ children being hand picked for psychiatric experiments. With or without the pretense of clinical trials, children in this country have become the little white mice in psychiatry’s living lab and all too often their real lives are the mazes we watch them stagger through. That’s not good enough.

March 20, 2010 at 10:22 am

Man vs Machine

Further on the topic of  Zyprexa and diabetes, Alaska lawyer Jim Gottstein of the Law Project for Psychiatric Rights is heading to court today to face down the drug’s maker, Eli Lilly in a lawsuit they brought against him for “conspiring to steal” documents that show the company suppressed information regarding the dangers of their star drug.

From Pharmalot:

For those who don’t recall, Gottstein…was accused along with two others by US District Court Judge Jack Weinstein of violating a court order by scheming to leak and publish sealed Zyprexa documents. The Zyprexa documents, which detailed hidden side-effect data and improper marketing, were published by The New York Times (Gottstein provides documents and related background here), setting off a feverish debate over the public’s right to know about concealed side effect data.

As a result of Jim going public with the information, Lilly agreed to plead guilty and pay a 1.415 billion dollar fine for promoting Zyprexa off label. $515 million of that was in the form of a criminal fine — the largest single corporate criminal fine in history. The rest was paid out as civil settlements to the states and the FDA. I don’t know how exactly anyone can pay out a record breaking fine and no one notices but then, the lack of media coverage regarding pharma’s indiscretions and outright deceit is always pretty puzzling. At least the important information was taken to the public and to a degree that has made people aware and force Eli Lilly to take some accountability.

As for Gottstein, he maintains innocence. ‘Ever since Judge Weinstein ruled against me on February 13, 2007, Lilly has threatened me with civil and criminal contempt sanctions and going after my license to practice law,’ Gottstein writes to supporters. “I believe I did nothing wrong – that when Lilly failed to object after being given a reasonable opportunity to do so and then Dr. Egilman sent the Zyprexa Papers to me, they had lost their secrecy protection. I hope the Second Circuit will agree.”

Forget for a moment that Gottstein is an outspoken advocate for informed choice in mental health. He’s a human being. If you know a company is suppressing the fact that its product is directly leading to thousands of deaths from children right up through our elderly and all stops between, don’t you have an obligation to let those people know? It takes people like Jim Gottstein to bring this level of systemic deceit to light because if recent history shows us anything, the corporate conscience isn’t going to do it and a judge who see this as a “trade secrets” issue and not a public safety issue isn’t going to do it.

February 2, 2010 at 4:29 pm

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