Friday, June 22, 2012

Unexamined, Preventable Drug Epidemic--the Elephant No One Wants To See

Alliance for Human Research Protection (AHRP)
Advancing Honest and Ethical Medical Research


“Prescription drug therapy stands as one of the most significant perils to health resulting from human activity.”
Prescription drugs are the 4th leading cause of death in the US. In any given month, 48% of US consumers ingested a prescription drug, and 11% ingested five or more prescription drugs.

Americans suffer from an estimated 45-50 million adverse effects, from prescription drugs--of which 2.5 million to 4 million are serious, disabling or fatal.

[QuarterWatch, May 2012]

So what is the FDA--the agency that licenses these drugs--doing to stem the rising tide of this preventable deadly epidemic?  NOTHING.

The FDA does not even monitor its own adverse event report database, MedWatch. Neither government agencies charged with setting healthcare policies, nor major stakeholders in medicine, are monitoring drug safety to identify which prescribed drugs are causing most serious harm. No one in authority is doing anything to prevent the escalating number of preventable human casualties.

Those who have argued for or against healthcare reform have ignored entirely the millions of Americans who are being harmed each year by toxic prescribed drugs. Adding insult to injury, most new drugs are not developed for life-threatening conditions. Professor Donal Light has demonstrated that only one in seven patented drugs offers a clinical benefit over existing, safer, and cheaper alternatives--and only 1% can be said to be "life-saving." []

To make a bad situation worse, Congress—whose members have been unable to agree on anything--reached quick bipartisan agreement with little bickering, without any effort to repeal the Obama administration's health reform law. They approved a massive $6.4 billion FDA-industry user fee agreement, well ahead of schedule, for brand-name drugs and medical devices, and introducing fees for the review of generic drugs. In the Senate (S3187) the vote was 96 to1, and in the House of Representatives a similar bill (HR5651) passed by a vote of 387 to 5.

Senate Backs Bipartisan Bill to Speed Drugs and Avert Shortages, by ROBERT PEAR, The New York Times, May 24, 2012.

JD Supra ]

Michael Carome of Public Citizen put it succinctly: “Industry heavily lobbied both sides of the aisle to get the provisions favorable to industry.  They were very successful.”

[GoozNews ] Lobbying and campaign contributions go hand in hand. By granting industry an accelerated approval process--which will increase profits--Congress rewarded its benefactors.

Most media reports applauded the legislation, without ever considering that user fees have already given industry undue influence over the FDA drug approval process. Neither did the media consider that by further accelerating FDA’s approval process--relying as it does on surrogate markers and non-inferiority trials--rather than evidence of clinical effectiveness or safety—will lead to the increased licensure of ineffective, harmful drugs and devices, that will have devastating consequences for patients.

Since May, 2008, the Institute for Safe Medication Practices, an independent nonprofit organization, has been monitoring FDA's MedWatch database, publishing quarterly reports (QuarterWatch).  The latest report found that in 2011, the FDA received 179,855 reports of serious, disabling, and fatal adverse drug events in the United States. This is an increase of 9.4% from 2010. In 2010 that number  increased by 21% from 2009. Since 1998, the percentage increases of reported serious adverse drug events were in the double digits.

Most reports (88%) were submitted by pharmaceutical companies and they involve patent-protected drugs. Company reports about deaths were found to be “nearly useless” in that they are vague, failed to report critical patient information, such as cause of death or age of patient.  Generic drug manufacturers rarely file adverse drug reports.

The authors—Thomas Moore, Curt Furberg, MD, PhD, and Michael Cohen, RPh, MS, ScD—point out that the most valuable barometer of drug safety risk is found in reports submitted directly to the FDA by physicians and patients. Unfortunately, the FDA estimates that serious adverse drug event reports submitted by physicians and patients constitute less than 1% of actual serious injuries. In 2011, physicians and patients submitted 21,002 adverse event reports to the FDA. These reports represent at least 2.5 million actual serious prescription drug injuries, including 128,000 deaths.

In 2011, the five leading drugs ranked by the number of direct adverse event reports from physicians or patients: anticoagulant drugs, Pradaxa and Coumadin linked to hemorrhage; antibiotic Levaquin linked to tendonitis, fatal allergic reaction, nerve damage resulting in pain, burning or numbness, and central nervous system abnormalities including depression, confusion; anti-cancer drug Carboplatin linked to bone marrow suppression; antihypertensive Lisinopril (Prinivil, Zestril) linked to dizziness, nausea, anxiety, insomnia, swelling, difficulty breathing.

The other valuable source of information documenting drug safety risk, are litigation-related adverse event reports submitted to the FDA.  The five drugs most frequently cited in litigation were patent-protected: the anti-nausea drug metroclopramide linked to tardive dyskenisia; the contraceptive drugs Yaz and Yasmin linked to blood clots and stroke; the anti-diabetes drug Avandia linked to heart attacks; the anti-smoking drug Chantix linked to suicide and homicide; and the acne drug Accutane linked to suicide.

Fifty-eight drugs carry FDA-mandated warning labels about the risk of suicide and suicidal behaviors. The most frequently identified drug posing a suicide risk in 2011, was SEROQUEL, with 197 reported cases. Seroquel was first approved for schizophrenia and manic depression (bipolar) but is now widely used for a variety of approved and unapproved conditions, including depression and as a sleep aid. The second ranked drug that poses a serious risk of suicide is Chantix a drug approved as a smoking cessation aid--with 187 reported cases. Indeed, since its approval for marketing in 2006, Chantix has been identified in reports to the FDA as a high risk factor for suicide and homicide.  Both of these drugs also pose serious cardiovascular risks.

A disturbing phenomenon has emerged, one that underscores the hazards of widely prescribed prescription drugs that are linked to the risk of suicide:

Drug use, especially stimulants, was banned in the US military 10 or 12 years ago.  But since the Iraq war many troop deployments are only approved if medications are prescribed. The Los Angeles Times reported that service personnel can be given 180-days worth of pills to take to combat zones, with nothing to stop them trading medicines or grabbing handfuls of pills to dull a stressful day in the battlefield.

1.      Military’s Rising Psychiatric Drug Prescriptions May be Linked to Suicides, Homicides by Kim Murphy, The Los Angeles Times, Aptil 7, 2012.

 “More than 110,000 active-duty Army troops last year took antidepressants, sedatives and other prescription medications. Some see a link to aberrant behavior.”

“After two long-running wars with escalating levels of combat stress, more than 110,000 active-duty Army troops last year were taking prescribed antidepressants, narcotics, sedatives, antipsychotics and anti-anxiety drugs, according to figures recently disclosed to The Times by the U.S. Army surgeon general. Nearly 8% of the active-duty Army is now on sedatives and more than 6% is on antidepressants — an eightfold increase since 2005.

“We have never medicated our troops to the extent we are doing now…. And I don’t believe the current increase in suicides and homicides in the military is a coincidence,” said Bart Billings, a former military psychologist who hosts an annual conference on combat stress.”

2.      Suicides Outpacing War Deaths for Troops by Timothy Williams,  The New York Times June 8, 3012

In 2006, the Hartford Courant uncovered a massive use of psychotropic drugs to keep the troops on the front lines, and a high suicide rate among the military. See: Mentally Unfit, Forced To Fight By LISA CHEDEKEL And MATTHEW KAUFFMAN, THE HARTFORD COURANT, May 14, 2006

Since then, the suicide rate among the military has increased at an alarming rate. A 2009 study by researchers from the VA, the University of Michigan and Columbia University  confirmed  that the highest risk period for suicide among veterans receiving treatment at a VA facility, are the first 12 weeks following the use of antidepressants:

Earlier this year, the NY Times reported that Active-Duty Soldiers Take Their Own Lives at Record Rate: 

2007--------115 suicides; 
2009-------162 ; 

3.      US Kids Getting More ADHD Drugs, Fewer Antibiotics June 19, 2012

Stimulant drugs on the market today are all variations of two molecules: amphetamine and methylphenidate, both mimic the action of dopamine in the brain. Substantial evidence exists demonstrating that stimulant medications may damage the nucleus accumbens, an area of the brain crucial to motivation and drive.

From 2002 to 2010, the use of psychostimulants grew by 46%--800,000 prescriptions a year.  Prescriptions for allergy medicines, cough drops and painkillers decreased, whereas prescriptions for birth control pills for children increased.

4.      Risky Rise of the Good-Grade Pill by Alan Schwartz, The New York Times, June 9, 2012

 “These are academic steroids. But usually, parents don’t get the steroids for you.”

The Times reported that:  “At high schools across the United States, pressure over grades and competition for college admissions are encouraging students to abuse prescription stimulants, according to interviews with students, parents and doctors.”

“As senior year began, when another round of SATs and one last set of good grades could put him over the top, the boy said he still had trouble concentrating. The doctor prescribed 30 milligrams a day. When college applications hit, he bought extra pills for $5 apiece from a girl in French class who had fooled her psychiatrist, too, and began taking several on some days.

The boy said that as his A-minus average continued through senior year, no one suspected that “a kid who went to Bible camp” and had so improved his grades could be abusing drugs. By the time he was accepted and had enrolled at a good but not great college, he was up to 300 milligrams a day — constantly taking more to stave off the inevitable crash.

One night, after he had taken about 400 milligrams, his heart started beating wildly. He began hallucinating and then convulsing. He was rushed to the emergency room and wound up spending seven months at a drug rehabilitation center.

To his surprise, two of 20 fellow patients there had also landed in rehab solely from abusing stimulants in high school.

 “The other kids in rehab thought we weren’t addicts because Adderall wasn’t a real drug. It’s so underestimated.”

But, as the Times reports, “The Drug Enforcement Agency  lists prescription stimulants like Adderall and Vyvanse (amphetamines) and Ritalin and Focalin (methylphenidates) as Class 2 controlled substances that have a medical use.

(By comparison, the long-abused anti-anxiety drug Valium is in the lower Class 4.   So they carry high legal risks, too, as few teenagers appreciate that merely giving a friend an Adderall or Vyvanse pill is the same as selling it and can be prosecuted as a felony.

But abuse of prescription stimulants can lead to depression and mood swings (from sleep deprivation), heart irregularities and acute exhaustion or psychosis during withdrawal, doctors say. Little is known about the long-term effects of abuse of stimulants among the young. Drug counselors say that for some teenagers, the pills eventually become an entry to the abuse of painkillers and sleep aids.

Paul L. Hokemeyer, a family therapist at Caron Treatment Centers in Manhattan, said: “Children have prefrontal cortexes that are not fully developed, and we’re changing the chemistry of the brain. That’s what these drugs do. It’s one thing if you have a real deficiency — the medicine is really important to those people — but not if your deficiency is not getting into Brown.”

The number of prescriptions for A.D.H.D. medications dispensed for young people ages 10 to 19 has risen 26 percent since 2007, to almost 21 million yearly, according to IMS Health, a health care information company — a number that experts estimate corresponds to more than two million individuals. But there is no reliable research on how many high school students take stimulants as a study aid

How long are Americans willing to subsidize a system that rewards the prescription drug industry for developing hazardous drugs that pose life-threatening risks rather than life-saving benefits?

Read more:

Vera Sharav

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