Posts Tagged ‘Food and Drug Administration’

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Antidepressant tied to heart risk

Friday, August 26th, 2011

Health24
August 25, 2011

High doses of the popular antidepressant Celexa (known as Cipramil in South Africa) can cause potentially fatal abnormal heart rhythms and should no longer be prescribed to patients, the US Food and Drug Administration has said.

Doses of Celexa (citalopram hydrobromide) greater than 40 milligrams a day can cause changes in the electrical activity of the heart, which can lead to abnormal heart rhythms, including a potentially deadly arrhythmia known as Torsade de Pointes, according to the agency.

Patients at high risk for changes in the electrical activity of the heart include those with pre-existing heart conditions (including congestive heart failure) and those prone to low levels of potassium and magnesium in the blood, the FDA said.

Read entire article:  http://www.health24.com/news/Depression/1-903,65865.asp

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Battling over happy pills

Tuesday, July 26th, 2011

The Boston Globe – July 26, 2011

by Alex Beam

A scholarly tug of war over treating mental disorders boils down to one question: Do antidepressants work?

In this corner: Dr. Marcia Angell, former editor in chief of the New England Journal of Medicine, senior lecturer in social medicine at Harvard Medical School, and frequent critic of the pharmaceutical industry. In the opposite corner: Dr. Peter Kramer, Brown University psychiatry professor and author of the mega-selling “Listening to Prozac,’’ a book that helped convince thousands of Americans to live better, chemically.

At issue: a two-part article by Angell, published in The New York Review of Books, that assails psychiatrists and their pharmaceutical helpmeets, mainly antidepressants, on several fronts.

Item: Angell, quoting, among others, Tufts University psychiatrist Dr. Daniel Carlat, attacks the widely held belief that depression and other mental disorders result from chemical imbalances in the brain.

Item: Citing the research of British psychologist Irving Kirsch, Angell writes that some of the most widely used antidepressants, including Prozac, Paxil, Zoloft, Celexa, and Effexor, performed only marginally better than placebos in Food and Drug Administration tests, a “clinically meaningless’’ result.

Item: Angell uses a book by journalist Robert Whitaker to suggest that newly minted antipsychotic drugs may be causing “an epidemic of brain dysfunction.’’

A few days after Angell’s essay appeared, Kramer published a lengthy essay, “In Defense of Antidepressants’’ in The New York Times. His key point: “Antidepressants work – ordinarily well, on a par with other medications doctors prescribe.’’ Kramer attacked Kirsch’s analysis of FDA drug trials, allowing that they can be “quick’’ and “sloppy,’’ and adding that the kinds of people who present themselves for drug research studies “are likely to be an odd bunch.’’

More convincingly, Kramer cited drug companies’ “maintenance studies,’’ in which patients successfully taking antidepressants switched to dummy pills. “If the drugs are acting as placebos,’’ Kramer wrote, “switching should do nothing.’’ But the drugs significantly reduced the odds of relapse. “These results, rarely referenced in the antidepressant-as-placebo literature, hardly suggest that the usefulness of the drugs is all in patients’ heads,’’ Kramer concluded.

What prompted Kramer to defend antidepressants? “I had never really come out and said that antidepressants work in ordinary ways for ordinary diseases,’’ he said. “Doctors work with these tools all the time. It’s true that these medications are imperfect, and we would all like them to be better, but we’ve all seen them work. You would have to start from a really suspicious stance to think that the whole enterprise is corrupt.’’

In an interview, Angell replied: “In his article, Kramer says it’s well established that antidepressants work for chronic and recurrent mild depression, but where is the evidence for that? That screams out for a reference. Should we believe it just because he says that?

“You can’t base judgments on anecdotes from clinical experience, because that can be very misleading,’’ Angell said. “I have faith in the evidence – in rigorous, randomized, double blind controlled clinical trials, and that’s the only way we can get at the facts. Medical history is filled with storytelling, and it is often wrong.’’

Whose side am I on? I’m biased. If there were a religion that combined the non-loony elements of Christian Science, Scientology, and Episcopalianism – a tall order, I know – I would sign right up. Psychoactive drugs frighten me. I embrace my dysphoria, although I am sensitive enough to realize that this isn’t a life strategy that works for everyone.

Also, I read Angell’s brilliant, anti-lawyer, anti-journalist book-diatribe, “Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case,’’ and loved it. I read Kramer’s “Listening to Prozac’’ and had trouble finding the handle.

So I appealed to Dr. Steven Hyman, former director of the National Institute of Mental Health, now a visiting scholar at the Broad Institute, for a second opinion. Angell cites some of Hyman’s work – incorrectly, he says – in her NYRB article, so I figured he would have read both her essay, and Kramer’s.

He had. Hyman didn’t have much to say about Kramer’s Times essay, other than to remark that it seemed a little hurried. He had read Angell’s article closely, and was quite familiar with Kirsch’s “Prozac as placebo’’ theories, and with Angell’s low opinion of pharmaceutical companies. “I agree with her that the marketing practices of the big pharmaceutical companies have been awful,’’ Hyman said. “But it’s a leap to say that mental illness is a pharmaceutical company invention.’’ http://www.boston.com/lifestyle/articles/2011/07/26/do_antidepressants_work/

Note from CCHR to Dr. Steven Hyman:  You’re actually correct in stating “it’s a leap to say that mental illness” [as it has been falsely pawned off on the public as a biological/medical condition] is a “pharmaceutical company invention.”  You’re right. It’s not.   Drug companies can’t vote mental disorders into existence, categorize behaviors or emotions as “disease” and then without a shred of medical/scientific evidence to support them as such – repackage these behaviors as “illness” and pawn them off on as unsuspecting public as disease.  Only psychiatry can do that.  Pharma simply funds psychiatry’s mass marketing campaigns.   For more information click here: http://www.cchrint.org/psychiatric-disorders/

 

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Bad Side-Effects Ahead For Pharma?

Thursday, June 30th, 2011

Forbes – June 30, 2011

by Martin Fridson

In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder.  The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books‘ recent two-part article (1)  by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks.  (All statistics and quotations herein are drawn from Dr. Angell’s article.)

It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so.  The profits in psychoactive drugs, however, make it tempting to flout the law.  In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Seeing that pharmaceutical marketing executives are evidently undeterred by the law, Dr. Angell, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, advocates a prohibition on prescribing psychoactive drugs off-label.

A ban would cut into a major growth area for pharmaceutical companies.

This growth is not a function of a few blockbuster drug discoveries. It parallels an extraordinary rise in the portion of the population, particularly children, diagnosed with mental illness.  For example, if diagnoses mirror the actual incidence of juvenile polar disorder, that affliction grew forty-fold between 1993 and 2004.

Have mental disorders genuinely proliferated that dramatically?  Dr. Angell suggests instead that the surge in certain diagnoses reflects a long-run shift in emphasis from “talk therapy” to medication.  This change just so happens to enable psychiatrists to see more patients and earn higher fees.  Not incidentally, with drugs now regarded as the preferred mode of treatment, the increase in diagnoses is a boon to pharmaceutical manufacturers.  The new generation of psychoactives has displaced cholesterol-reducing medications as the biggest-selling class of drugs in the U.S.

Also benefiting from the present arrangement are low-income families that receive Supplemental Security Income (SSI) payments on the basis of mental disabilities.  To qualify, applicants (children included) generally must be taking psychoactive drugs.  Getting into the program usually also ensures that the family will qualify for Medicaid.  The disbursements can be so substantial that MIT economics professor David Autor describes SSI as “the new welfare.”

The parents and two siblings of Rebecca Riley, the four-year-old who died from the effects of off-label drugs, were all on psychoactive drugs and were receiving about $30,000 a year from SSI.  Dr. Angell links the astonishing rise in diagnoses of certain mental disorders to the huge financial stakes of physicians, pharmaceutical companies and SSI recipients.

I do not want to portray this issue as an imminent or mortal threat to pharmaceutical stocks. If a ban on off-label prescription of psychoactive drugs were proposed in Congress, the companies’ lobbyists probably could stave it off for a long time.  Furthermore, the major pharmaceutical companies have widely diversified product lines, so a setback in the psychoactive category, even though it is a major growth area, would not be a body blow.

Still, this topic is one to keep an eye on for investors who hope to gain an edge by seeing beyond the quarterly EPS data.  Psychoactive drugs have been around since the 1950s, but parents can readily observe that their use with children is far more widespread than it was a generation ago.  If advocates such as Marcia Angell can make a persuasive case that the change is not fully justified on medical grounds, yet poses significant health hazards, is it unrealistic to expect a public opinion backlash some day?

[1] Marcia Angell, “The Epidemic of Mental Illness: Why?” The New York Review of Books (June 23, 2011), pp. 20-22 and “The Illusions of Psychiatry” (July 14, 2011), pp. 20-22.  The article is a review of three books on the contemporary practice of psychiatry by Irving Kirsch, Robert Whitaker, and Daniel Carlat.

http://blogs.forbes.com/investor/2011/06/30/bad-side-effects-ahead-for-pharma/

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In shift, feds target top execs for health fraud

Tuesday, May 31st, 2011

Associated Press
May 31, 2011

Lewis Morris, general counsel for the Department of Health and Human Services inspector general, poses for a portrait in his office in Washington, Thursday, May 26, 2011. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.

The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.

Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.

Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.

The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.

“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes & Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”

Others say high-powered corporate targets won’t go meekly.

“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”

Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.

Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.

A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.

The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”

Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.

The company said it had considered the case closed. But then came the inspector general’s letter.

“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”

Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”

Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.

The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.

It’s making an entire industry nervous.

Read article here:  http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

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Is ADHD a Fictional Disease?

Saturday, May 21st, 2011

Some psychiatrists argue that ADHD is little more than a marketing gimmick

The Mark
By Fred Baughman
May 18, 2011

Dr. Fred Baughman, Child neurologist; opponent of ADHD diagnosis

Some 5.4 million children in the United States have been diagnosed with attention-deficit hyperactivity disorder, or ADHD, with two-thirds of them taking psychiatric drugs. Sales of ADHD drugs reached $1.2 billion in 2010, a demand level so high that the U.S. is experiencing an ADHD drug shortage. But an increasingly vocal contingent of psychiatric experts is speaking up against diagnosing children with ADHD, arguing it is a non-existent condition drummed up by pharmaceutical companies to increase sales.

What makes you convinced that ADHD is not a real disease?

During my time in practice, I’ve authored papers and discovered real diseases and so on. Psychiatry in 1948 was distinguished from neurology. Neurology is the specialty dealing with physical and organic diseases of the brain and nervous system. Psychiatry is the specialty dealing with emotional and behavioural things which are not actual, physical diseases – things like depression, anxiety, panic, and so on.

Insofar as ADHD is concerned, it seems clear that in the ’50s, as the first psychiatric drugs came to market, that psychiatry – in cahoots with the pharmaceutical industry – came upon the market strategy of, “Well, we’ll call these things ‘diseases.’” And the prototypical invented disease was called ADHD.

It was initially in a 1970 congressional hearing in the U.S. that psychiatrists appeared and testified that, what was then called hyper kinetic disorder or minimal brain dysfunction, was a disease that needed diagnosing by a physician, and as a disease it justified the use of drugs to treat it. So that was the official beginning of ADHD in particular and of psychiatric diagnoses in general as being due to a disease of the brain. In every case, they say there’s a subtle chemical imbalance in the brain, which of course they never have a means of diagnosing in life and have never in scientific literature authored proof that there is in fact a disease. And yet they are allowed by [the U.S.] Food and Drug Administration to say that there is a chemical imbalance and that the drugs balance the imbalance.

So it’s been a market strategy. This lie has been allowed to be published by the drug industry and by psychiatry, by our regulatory agencies, specifically the Food and Drug Administration. So that’s where we are today.

All physicians learn in medical school that a disease is a physical abnormality. When you go to your physician, they may see a rash or they may find something microscopically abnormal, such as cancer cells. Then there are a lot of chemical diseases – diabetes being the best known. There are about a hundred examples of inborn errors of metabolism or body chemistry. These can all be tested for, they’ve all been proven, and they exist in the scientific literature – whereas there is not a single psychiatric diagnosis that exists in scientific literature of the world.

In 2008, I was counselling a young father from Kingston, Ont., who was in a divorce situation, and the mother insisted the children be seen by psychiatrists and the psychiatrist had made a number of diagnoses and had this one boy on large amounts of about five or six different types of medication. I helped the father author a letter to Health Canada asking where – in the case of ADHD or any psychiatric diagnosis – there is proof of a gross or microscopic abnormality.

This gentleman got a letter back from the director-general of Health Canada saying there is no gross, microscopic, or chemical abnormality in any psychiatric diagnosis; there is no objective way of verifying a psychiatric diagnosis as a disease.

That’s why psychiatry’s claims that their diagnoses are chemical imbalances is nothing but a lie and a deception. And yet, because of their financial might on the world scene, no one will challenge them. They have friends bought and paid for in government and in all of the governmental health-care agencies.

Here in the States, as of 2007, the Centers for Disease Control announced that 5.4 million U.S. schoolchildren five to 17 years old had ADHD. And you can be sure that they have all been on ADHD drugs, which are, for the most part, amphetamines, which are known to be addictive, dangerous, deadly.

I’ve heard estimates of 20 per cent of schoolchildren in the U.S. with a psych diagnosis and who were on psych drugs. It’s exploding, it’s increasing all the time.

Is the issue that we’re overmedicating ourselves, or that ADHD is not real?

When it’s a total fraud, you don’t call it overmedicating. There is no such thing as ADHD as a disease, so there is never justification for it. It’s a total fraud.

What is there to gain from diagnosing children with ADHD?

Ritalin has passed $1 billion a year in sales. Ritalin is no longer the top ADHD drug in the U.S. I think Adderall, which is made up of amphetamines, passed Ritalin a few years ago in market share.

It’s a complete fraud, they’ve invented diseases for which their drugs are a cure. The rate of diagnosing ADHD has been going up by a million a year in the U.S. This is a market strategy.

The book Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients [by Ray Moynihan and Alan Cassels] talks generally about inventing diseases for which to sell drugs. In the foreword of that book, the authors quote the former president of Merck Pharmaceutical Co., Henry Gadsden, who once said he was anxious to find ways to market his products to normal people, just like the Wrigley chewing gum people did. This was kind of an after-the-fact confession they were trying to market drugs to normal people, and calling all psychological dilemmas diseases for which they needed a pill. This was the strategy.

It’s almost unimaginable, it’s almost unthinkable that this has been going on, but that’s exactly what’s been going on.

How would you diagnose a child that was considered to have ADHD?

Look at the criteria that are used to call a child ADHD. They talk out of turn, they don’t sit still, they wiggle around too much in their seats, they are impulsive, disorderly, and so on. It’s a bunch of behaviours that are seen in just about every child at some stage of their life. This is by design; they have taken kind of irritating, bothersome, disruptive behaviours in children and have kind of cobbled them together and called it a disease.

They get a lot of parents to buy it because a lot of parents are now busy with their job in the workforce and there’s no longer a full-time parent in the home, and so, “Here’s why Johnny or Janey is such an irritant to me, they’ve got ADHD.” It takes the pressure entirely off the parent for not being a presence and for not being there full-time to mould the behaviour of the child, and they’re calling these behaviours a disease and saying we’ve got a pill for it. That’s very seductive. That’s a far more appealing analysis than, “Gee, you’re divorced, there’s no one in the home to discipline the child real time,” and so on.

These are not diseases, they are behaviours. Today, you hang a psychiatric label on a child, you surely stigmatize the child and these drugs are exceedingly dangerous. In 2005, there were several deaths in Canada of young children from Adderall. It was temporarily taken off the market, but then the power of the industry won out and Adderall’s back on the market. Pure amphetamines.

Read article here:  http://www.themarknews.com/articles/5193-is-adhd-a-fictional-disease?page=1

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Antipsychotic Drugs Called Hazardous for the Elderly

Monday, May 9th, 2011

The New York Times
By Gardiner Harris
May 9, 2011

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, a government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the audit found, costing the program $116 million for those six months.

“Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions,” Daniel R. Levinson, inspector general of the Department of Health and Human Services, wrote in announcing the audit results.

Mr. Levinson noted that such drugs — which include Risperdal, Zyprexa, Seroquel, Abilify and Geodon — are “potentially lethal” to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses “putting profits before safety.”

The audit is an unusual assessment by the government of whether doctors are treating Medicare patients appropriately in nursing homes. Mr. Levinson suggested that the government should collect information on the diagnoses given Medicare patients so that the government can assess whether the drugs prescribed to them are appropriate.

While common in the private sector, such basic oversight is unheard of in the Medicare program and would almost certainly be opposed by doctors’ groups and many in Congress who view government intrusions into the doctor-patient relationship as inappropriate. In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

Medicare officials said that diagnosis information is not generally included with prescriptions so the government cannot assess in real time whether prescription payments are appropriate.

While the Food and Drug Administration has warned doctors that using antipsychotic drugs in elderly patients with dementia increases their risks of death, doctors continue the practice because they have few other good choices, said Dr. Daniel J. Carlat, editor in chief of The Carlat Psychiatry Report, a medical education newsletter for psychiatrists.

“Doctors want to maximize quality of life by treating the patient’s agitation even if that means the patient will die a bit sooner,” Dr. Carlat said.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

The auditors found that 83 percent of antipsychotic prescriptions for elderly nursing home residents were for uses not approved by federal drug regulators, and 88 percent were to treat patients with dementia — for whom the drugs can be lethal.

“These results are alarming,” said Senator Charles E. Grassley, Republican of Iowa, who asked for the audit. “Medicare officials need to pay attention.”

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

Government rules also ban drugs that are used in excessive doses or duration, even if patients are found to have a condition for which the drug is appropriate. Auditors found that 22 percent, or 317,971 of 1.4 million claims, for antipsychotic medicines failed this standard.

Read article here:  http://www.nytimes.com/2011/05/10/health/policy/10drug.html?_r=2

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FDA Advisory Panel Recommends Electroshock Machine Too Risky For Reclassification to Less Dangerous Device

Monday, January 31st, 2011
A panel of the U.S. Food and Drug Administration (FDA) recommended Friday that devices used to deliver ECT, or psychiatric shock treatment, remain in the most high-risk category (Class III), reserved for the most dangerous medical devices.

January 31, 2011

by CCHR International— The Neurological Devices Advisory Panel of the U.S. Food and Drug Administration (F.D.A.), recommended Friday that devices used to deliver shock treatment, also known as electroconvulsive therapy (ECT) remain in the most high-risk category (Class III), reserved for the most dangerous medical devices and not be downgraded to a lower risk category.  In so doing, it recommended that the companies which manufacture ECT devices be required to prove that ECT is both effective and safe in order to remain in use.

ECT has long been known to cause serious harm to patients, including extremely severe and permanent memory loss, inability to learn and remember new events, depression, suicide, cardiovascular complications, prolonged and dangerous seizures and even death.

Patients who have undergone ECT felt vindicated by the decision, saying the ECT device is dangerous and causes irreparable harm.  The chairman of the advisory panel, Dr. Thomas G. Brott, a Professor of Neurosciences, at the Mayo Clinic expressed concern about 100,000 people being given ECT each year in the U.S., yet psychiatrists had not bothered to conduct MRI scans before and after the procedure to monitor potential brain damage.

Ms. Jan Eastgate, President of the Citizens Commission on Human Rights (CCHR), a psychiatric watchdog, spoke at the Hearing and was critical of the ECT device manufacturers, Mecta and Somatics, Inc. for their failure to conduct safety studies and submit a Pre-Marketing Application (PMA), while making more than $30 million from sales of the machine over the past 3 decades.  She said psychiatrists claiming that a PMA would be “too expensive” had put profit above patient safety— With ECT costing between $1,000 and $2,500 a treatment, psychiatrists had made more than $28 billion during the same period.

The hearings were prompted by a GAO investigation in January 2009 resulting in a report stating the FDA must examine all devices which had remained for a substantial time in Class III without critical evaluation of safety and effectiveness. The GAO said the FDA should take steps to ensure that high-risk device types are approved through the most stringent review process reserved for new machines coming on to the market which may be potentially dangerous.

The FDA Office of Medical Device Evaluation thereafter called for hearings before a panel of experts to advise the FDA whether shock devices could be downgraded to Class II – and therefore require little review – or remain in the highest risk category with a mandated approval process with stringent clinical trials. The FDA Advisory Panel agreed that this device was sufficiently dangerous to require that it remain in Class III.  It is up to the FDA whether to act on the recommendations of the panel.

Ms. Eastgate said the decision is the first step towards getting needed greater protections for patients but said there were still considerable concerns about the F.D.A.’s handling of the safety and efficacy issues concerning ECT.  She said there are potential conflicts of interest with psychiatrists helping write the F.D.A.’s Executive Summary on ECT and advising the agency about the procedure.

Watch video: Electroshock—It’s Not Treament, It’s Torture

here:  http://www.youtube.com/watch?v=QDR3cD8_kck

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Drug-Company Tweeting: Still Awaiting FDA Rules

Wednesday, December 29th, 2010

Note from CCHR:  Let’s  see if we’ve got this straight…..last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. The company also paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes.  Other corporate violators included GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.  Criminal or civil illegalities included  (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution. And after all that, the FDA is going to allow Big Pharma to launch into social media?   Seriously?  The article below claims the FDA monitors drug ads –for accuracy.  No they don’t.  The FDA doesn’t bother verifying the ads big Pharma inundates us with on TV & in print, to ensure these ads are not fraudulent or misleading even though its the FDA’s job to do this, and now they’re going to let Big Pharma loose on social media?   Sounds to us  like once again,  the FDA has Big Pharma’s back instead of the general public’s.

TIME Magazine  – December 28, 2010

Tweets are supposed to be quick and to the point, but the Food and Drug Administration (FDA) is neither in its ever lengthening quest to tell the world’s drugmakers how they can promote their potions via Twitter, Facebook and other social media. More than a year ago, after criticizing 14 pharmaceutical companies for posting misleading messages on such sites, the FDA held hearings on the topic and declared it would issue rules by the end of 2010. Now it’s delaying them until sometime early next year, perhaps later.

For more than a decade, the FDA has regulated how drug companies sell their products in newspapers, magazines, television and radio. But as the rest of the business world jumps into booming social-media marketing, there are no rules yet for medicine merchants. The pharmaceutical industry had hoped the FDA would stick to its pledge and issue guidelines this year. Earlier this month, in fact, agency officials said that was still the plan. But last week, the FDA office responsible for drafting the new regs said, without elaboration, that it is going to wait at least until the first quarter of 2011 before issuing them. (See TIME’s best pictures of 2010.)

The companies wish the agency would act. “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making,” the drugmaker AstraZeneca has told the FDA. “In our absence, consumers will turn to information sources that are not regulated and not always well informed.” Not everyone agrees the companies have such altruistic aims. The Center for Digital Democracy (CDD), a consumer group based in Washington, D.C., that is focused on marketing and public-health issues, has told the FDA to take as much time as it needs. The agency, says Jeff Chester, CDD’s executive director, “needs to take a deep breath, and shouldn’t open the floodgates and allow pharmaceutical companies to purposely mislead consumers.” (See how drug companies are taking their pitch to social media.)

Despite such qualms, there’s reason to be concerned by the foot-dragging. About 60% of U.S. adults get health information online, often for a partner or child. We’re what experts call “e-patients,” who regularly march into doctors’ offices demanding prescriptions for what ails us. Many of us pore over the Internet, seeking ways to get better, and often surrender personal information to get it. The drug industry surely recognizes the value of such online contact, and is steadily increasing the share of its $4 billion annual marketing budget dedicated to online offerings.

Yet tough questions need to be answered before Big Pharma starts tweeting about our tummy aches. How can drug companies safely sell their products — which often require pages of fine print or speed-talking announcers — in a 140-character tweet? If a drug’s risks and benefits are wrongly cited in a Wikipedia entry, is the company responsible for correcting it? Does that then become advertising regulated by the FDA? Does the drug industry’s proposal to include a symbol, inside a tweet, that links consumers to more detailed information make sense? (Comment on this story.)

It’s enough to give you a headache. In which case, you may want to take two tweetless aspirin, along with a dollop of patience, while awaiting the FDA’s rules.
Read more: http://www.time.com/time/business/article/0,8599,2039794,00.html#ixzz19WlEIgcZ

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“Sunshine: Best Rx for good medicine” by U.S. Senator Chuck Grassley

Wednesday, November 24th, 2010
The Daily Nonpareil, November 24, 2010
By  Chuck Grassley, U.S. Senator

As Americans count their blessings during this season of thanksgiving, many of us can be thankful to gather around the holiday table with multiple generations of family and friends. More Americans are enjoying greater longevity and an improved quality of life well beyond retirement. In 21st century America, the bar of expectation has been raised for each successive generation not only to live the American Dream, but also to live longer and healthier than those before us. Many of us can thank modern medicine for creating breakthrough cures and treatments.

As the taxpaying public shoulders a growing share of the nation’s health care spending, it’s important now more than ever to protect the integrity of each tax dollar and strengthen the integrity of the U.S. health care system.

That’s why I’ve focused for the last several years to improve transparency and accountability between health care providers and the pharmaceutical and medical device industries.

In 2004 I began an inquiry regarding the financial ties between Food and Drug Administration advisory board members and the drug industry. Later, I broadened my scope to include the National Institutes of Health in order to assess its effectiveness in monitoring conflicts of interest between the industry and medical researchers.

It became clear more transparency was needed. In my work in public office, I’ve found sunshine to be very effective in revealing problems and promoting good behavior.

Starting in 2007, I led a bipartisan legislative effort to bring transparency to the financial relationship between drug and medical device makers and doctors conducting research or practicing medicine.   My “Physician Payments Sunshine Act,” which became law this year as part of health care reform, will require all payments above $10 from drug and device makers to physicians to be reported every year by the drug or device company. A user-friendly data base will be available to the public, so that anyone can see industry payments to physicians prescribing treatments and medical researchers conducting studies whose outcomes can significantly influence the commercial success of a drug or device.

The pharmaceutical industry spends tens of billions of dollars every year to market its products to providers. Some physicians receive industry payments for speeches, consulting activities, travel and research. While these payments are often a good and necessary part of drug development, they can also create bad behavior when kept hidden from the public.

In the past few years, congressional investigations and state gift disclosure laws have raised eyebrows about these financial connections, especially where the amount that has been publicly reported is vastly less than what has actually been paid. For example, a congressional review I led from my position on the Senate Finance Committee revealed a troubling financial link between a drug maker and a child psychiatrist at Harvard, whose work led to a significant spike in diagnoses of pediatric bipolar disorders and prevalent use of antipsychotic medicines for children.

Separately, an orthopedic surgeon at the University of Wisconsin received more than $19 million from a medical device company, although he reported only receiving “more than $20,000” per year on his financial disclosure records to the university.

My sunshine legislation that’s now law will require the pharmaceutical and device industries to collect information on their payments to physicians beginning in 2012 and submit it to the Department of Health and Human Services by March 2013 and annually thereafter. The Department of Health and Human Services is required to make that payment information available to the public starting in September 2013. Some within the industry already are developing self-reporting requirements in response to the effort.

While I’m glad to see companies, manufacturers, universities and even the National Institutes of Health are getting a head start to increase disclosure, I’m concerned the information could create even more confusion because the data is not standardized.

That’s why I am working closely with the Department of Health and Human Services to ensure the implementation of the sunshine law works as intended. That means the data must be made available in a timely, user-friendly format.

This effort has been part of my continued work to build openness and establish accountability for taxpayers. Banning anonymous “holds” in the U.S. Senate would shine the light of day on lawmakers who delay the people’s business. I’ve said lawmakers who take issue with a specific bill or nomination ought to have the guts to stand up and say so.

Likewise, creating a meaningful database of financial ties between Big Pharma and medical researchers ought to strengthen our health care system. Financial ties should withstand the light of day.

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Forest Labs settling wrongful death & personal injury lawsuits from parents of kids who took Celexa & Lexapro

Monday, November 1st, 2010

Stltoday.com

by Jim Doyle

A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug’s clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.

Four of the cases were settled Friday, and two additional cases were settled in recent weeks.

A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.

Last month, the company’s subsidiary — Forest Pharmaceuticals, based in Earth City — agreed to plead guilty to criminal charges involving its marketing and manufacturing practices and also to pay more than $300 million in criminal and civil penalties. The U.S. attorney’s office in Boston is continuing to investigate the potential criminal liability of Forest officers and employees.

According to federal regulators, Forest waged an aggressive campaign from 1999 through at least 2005 to promote the use of Celexa and Lexapro in children and teenagers, although neither drug was approved for pediatric use.

Details of Forest Laboratories’ monetary settlements with aggrieved families have not been made public, but the lawsuits themselves present a glimpse of the alleged harm caused by the company, including hefty payments to pediatricians and other physicians to tout the benefits of the drugs.

In vivid detail, the complaints allege that children under the influence of Celexa and Lexapro committed acts of suicide and violence. And the victims’ families accuse the pharmaceutical company of fraud and negligence in failing to warn physicians and the public about the drugs’ known dangers.

But the settlements are cloaked in secrecy, with each side vowing not to disclose the dollar amounts paid or other aspects of their agreements.

Frank Murdolo, the chief spokesman for Forest Laboratories, was unavailable for comment.

Harris Pogust, a Pennsylvania attorney who is the plaintiffs’ lead counsel in the multidistrict litigation, said, “I can’t really discuss anything that’s going on between the parties.”

The Celexa and Lexapro cases have been consolidated in federal court in St. Louis.

Several years ago, some of Pogust’s clients testified before Congress and the Food and Drug Administration about the dangers of marketing the drugs to children.

One of the cases settled Friday involves Andrew Tradd of Massachusetts, who was 13 when he tried to hang himself in April 2004. Seven days later, he died as a result of a brain injury suffered in that attempted suicide. He had been prescribed Celexa in 2002.

According to his family’s lawsuit, Forest was aware through numerous studies that some patients taking Celexa and similar drugs were much more at risk of suicidal behavior but chose not to warn physicians or strengthen the warning on the drug’s packaging.

Celexa’s sales skyrocketed from $92 million in 1999 to $1.6 billion in 2002. But the firm was under pressure to sell as much of Celexa as possible because the U.S. patent on the drug would expire in 2004.

H. Lundbeck, a Danish firm that developed Celexa, had placed a suicide warning on the drug in Europe for many years but not in the United States — until a “black box” warning was mandated for Celexa and similar drugs in 2004 by the FDA.

The Tradd lawsuit and another suit quote Howard Solomon, the chairman and chief executive of Forest Laboratories, as saying in a letter to shareholders, “We believe that the studies and experience with our products, Lexapro and Celexa, do not indicate any increased suicidality.”

But the Tradd family alleged that “contrary to these claims, for years Forest Laboratories Inc., was aware of clinical trials that showed that some persons who took Celexa suffered damaging side affects including agitation, aggressive and suicidal tendencies.”

Another settled case involves Rachel Weiss of Belchertown, Mass., who was 16 in November 2002 when she suffered a panic attack while at school. En route to the school nurse’s office, her suit alleges, Rachel threw herself down concrete and metal stairs, causing permanent injuries to her back and spine.

A high school sophomore, she had been taking Celexa for about nine days for depression and anxiety. After she began taking Celexa, the suit alleges, “her symptoms worsened dramatically.”

In 2002, a four-year clinical trial by the Danish Lundbeck firm revealed that Celexa did not help depressed adolescents more than a placebo. But the results were not made public until 2004, when they appeared on a single line of a chart contained in a Danish textbook, the suit alleges.

The U.S. attorney’s office in Boston has asserted that the results of the Lundbeck trial had been provided to Forest two years earlier, but the company chose to keep the negative results hidden from the public.

Another settled case involved Danielle Henrikson, who was 15 when she hanged herself in the garage of her parents’ Idaho home in July 2004. Within a few weeks after taking Celexa, their lawsuit alleges, her condition began to deteriorate.

“The company suppressed the negative results of some studies, which showed that Celexa could cause an increased risk of suicidal thinking and acts in those adolescents who were prescribed to it,” the suit alleges.

Forest Laboratories denied the allegation in court documents.

A case settled Friday was on behalf of Alex Kim of Gwinnett County, Ga., who hanged himself in June 2004 when he was 13 after his Lexapro dosage had been doubled. He had been taking the drug for about three months.

In their lawsuit, Alex’s parents asked for $10 million in general damages, plus $10 million in punitive damages from Forest for “failing to provide information regarding serious health risks, failing to publicize the risks, failing to timely alert the public, and failing to recall the product.”

Read the rest of the article here: http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html

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