Truth, Belief, and Human Survival

September 24th, 2013

Not a day passes when we don’t hear about the perils of HRT, antidepressants, “carbs”, cholesterol, sodium excess, gluten, and the importance of proper diet to protect us against obesity and diabetes, cancer, heart attacks, and death itself. Modern life as mirrored in the media, via our “devices”, hand-held and otherwise, offers 24/7 stimulation. This arrives in the form of entertainment, news, and advertising. Sadly, we are all drowning in “information,” whether it is advertising or government edict disguised as medical truth, or opinion parading as received wisdom. Public confusion reigns. The City of New York and other cities, decides to mandate the amount of trans fat allowed to be served in restaurants, the medical sovereigns or the Government tells us we will die of high blood pressure if we don’t restrict salt intake-the list goes on. In my opinion and that of others,  most of these decisions have been verified by a plethora of Junk Science. Many such beliefs edge into a form of snobbery when skeptics are ridiculed. We all want to be “right” and politically correct, even if, for example, Federal dietary guidelines change every few years or spectacular new medical treatments, such as anticoagulants and robotic surgery are proven to be dangerous.

Once we begin to acknowledge that life is all about uncertainty, we are still left with that slippery word, “truth”, and its fashionable costumes of faith and belief. Ultimately, we are left to deal with faith, reason, and the actual basis of knowledge. According to Gallup, 40% or 125 million of Americans take a literalist view of creation, believing that God created the universe, (either in millions of years or in 6 days), but place the big bang “2,500 years after the Babylonians and Sumerians learned to brew beer.” Only 17% of us doubt that a personal God has authored the Bible, let alone created the earth and its 900,000 species of insects. As Sam Harris in The End of Faith also observes, “A survey of Hindus, Muslims, and Jews around the world would surely yield similar results revealing that we, as a species, have grown almost perfectly intoxicated by our myths.” Can the human race, its very existence now imperiled by the clash of beliefs and civilizations, afford to drift entirely free of reason and evidence?

Perils of Prescription Drugs

July 1st, 2012

The Institute for Safe Medical Practices, ISMP or  Quarterwatch  , is an invaluable independent non-profit organization monitoring domestic events of all serious drug reactions reported to the FDA.  The Institute has issued a chilling summary for the calendar year of 2011 based on their analysis of  reports to the U.S. Food and Drug Administration: An estimated 2 to 4 million persons suffered serious, disabling, or fatal injury associated with prescription drug therapy. This figure is arrived at by the FDA’s own estimate-proven in previous studies over the past decades- that less than 1% of all serious adverse events are reported directly to it. Among the almost 180,000 reported cases in 2011, 88% were collected, written, and submitted by drug manufacturers, and only 12% were submitted directly to the FDA by health professionals and patients. “Many factors influence manufacturer reporting of adverse events. A company actively marketing a brand name drug may learn of adverse events when its sales force calls on physicians, and through consumer hotlines and assistance programs. On the other hand, the multiple manufacturers of a generic drug have little contact with physicians and patients and seldom learn of events to report. This and other variability is avoided with direct reports to the FDA because all events can be reported to a single FDA web site or 800 number, 1-800-332-1088 for OTC drugs.  See FDA.gov

Using 2011 report totals suggests that there would have been an estimated 2 million or more cases of serious injury, including 128,000 patient deaths. The most frequently identified drugs in direct reports to the FDA were the anticoagulants dabigatran (PRADAXA) and Warfarin (COUMADIN), showing that inhibiting clotting ranks among the highest risk of all drug treatments. In addition, they “identified nine other drugs associated most frequently with five clinically relevant, drug-related injuries, and show the drugs most frequently the target of lawsuits.”  Additional “top” drugs include LEVOFLOXACIN (LEVAQUIN), CARBOPLATIN, LISINOPRIL, ZESTRIL, Reglan (Metoclopramide) and 350 other drugs.

FDA is looking at whether bleeding is happening more frequently than should be expected with Pradaxa which is in the newer  medication class of thrombin inhibitors. There is no rapid current method of stopping bleeding caused by this drug.  Thus, one of the major Pradaxa side effects is serious bleeding which cannot be stopped.

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More on Direct to Consumer Drug Advertising

November 26th, 2011

Tremendous growth has occurred in direct-to-consumer pharmaceutical advertising  since 1998.  According to Pharma Marketing News (Pharmacy and Therapeutics, October 2011) spending in dollars rose from $1.2 billion in 1998 to $2.5 billion in 2000 and 4.5 billion in 2009, a 450% increase.

As I pointed out three years ago, prescription drug marketing directly to the consumer is routinely permitted under U.S. law. Notable, is the profoundly different regulatory environment in the European Union (EU), Australia, and Canada where pharmaceutical manufacturers are forbidden to advertise prescription drugs to the public.  Incredibly,  the U.S. and New Zealand are the only two countries in the world where it is legal for drug companies to advertise to the public.

Such “direct to consumer” or DTC advertising is meant, obviously, to create increased patient demand for specific drugs from their doctors. In this scenario, patients really become consumers, replacing the doctor as prescriber, if the physician is foolish enough to surrender his authority. Consumer Reports, in a 2006 survey found that 78 percent of doctors said that patients asked them at one time or another to prescribe drugs they had seen advertised on television.

While Congress recently gave the FDA more authority to regulate ads, it rejected a measure that would have allowed to agency to place a moratorium on ads for new drugs that raise safety concerns. The sad fact remains that Congress seems in no mood to address the main problem, the legality of advertising drugs to the public.

Don’t expect the ad barrage, TV or otherwise, to subside any time soon.  Evening and much of daytime TV is contaminated with advertising for various pharmaceutical products, including new antidepressants, new treatments for arthritis,  heart disease, diabetes, sexual malperformance-who can define “erectile dysfunction”?-a host of new anticoagulants-I could go on indefinitely. What I like best are the disclaimers:  Here’s an example from Chantix:

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

The real question is, why would anyone in his right mind take Chantix to stop smoking?  Or for that matter, a few hundred other drugs festooned with all those scary disclaimers.

U.S. Health Care Spending vs. Major Countries

August 12th, 2011

иконографияКартини

  • Health  care spending towers over other major industrial countries.  In 2008, hospital spending per discharge in the U.S. dwarfed all major industrial countries at $16,708.  This is nearly triple  the median of $5,949  according to the  Organization for Economic Cooperation and Development (OECD).  This analysis concentrated on 2010 OECD health data for Australia, Canada, Denmark, France, Germany, Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States. including the supply, utilization, and price of diagnostic imaging.  The country with the second-highest spending, Canada, spent only 75 percent as much per discharge ($12,669), and in both Germany and France, hospital stays were nearly one-quarter as expensive ($4,566 and $4,762, respectively.

This enormous difference in spending occurs despite the fact that the U.S. has fewer hospital beds and physicians, and sees fewer hospital and physician visits than in most other countries. Prescription drug utilization, prices, and spending all appear to be highest in the U.S.  OECD  tracks and reports on more than 1,200 health system measures across 34 industrialized countries. U.S. performance on other measures is variable. We ranking highly on five-year cancer survival, fair on in-hospital case-specific mortality, and poorly on hospital admissions for chronic conditions and amputations due to diabetes.

Shocking, isn’t it?  Stay tuned.
__________________________________

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April 10th, 2011
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Knee and Hip Ops Almost Doubling in 10 Years

April 4th, 2011

Between 1996–1997 and 2006–2007, inpatient procedure rates among persons 45–64 years of age doubled for total knee replacements (from 12 to 26 per 10,000 population) and almost doubled from 7 to 12 per 10,000 population, for total hip replacements.

During this period, inpatient procedure rates for excision of intervertebral disc and spinal fusion, which are typically not performed on an outpatient basis, were unchanged among this age group.

Among persons 65 years of age and over, excision of intervertebral disc and spinal fusion procedure rates increased 67%, from 17 to 28 per 10,000 population, and total knee replacement procedures increased 60%, from 51 to 82 per 10,000 population, during this period. Stay tuned.

Are there that many more patients who require hip and knee replacements as well as spinal operations, or have the indications for performing these procedures changed that much in 10 years? What is the new complication rate? Stay tuned.

Source: National Center for Health Statistics. Health, United States, 2010. http://www.cdc.gov/nchs/data/hus/hus10.pdf

Criminal and Civil Penalties Against Big Pharm

December 29th, 2010

The Public Citizens Health Group recently reported U.S. spending on prescription drugs has increased from $40 billion in 1990 to $234 billion in 2008.  During this period, escalating drug costs have contributed to such inflated spending that  illegal pharmaceutical company activities are finally beginning to attract media attention.

Reported in major publications, recent billion-dollar settlements  with two of the largest pharmaceutical companies in the world, Eli Lilly and Pfizer, demonstrate the enormous scale of this wrongdoing.  However, according to The Public Citizen’s Health Group, the extent,  size,  and potential impact of these illegal and dangerous activities have not been previously analyzed.

Their study examined trends from 1991 to the present in federal and state criminal and civil actions against pharmaceutical companies by compiling a comprehensive database  to identify all settlements of at least $1 million during the past 20 years.

Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).  Four companies, among the largest in the world, (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades.

“While the defense industry used to be the biggest defrauder of the federal government under the False Claims Act (FCA), … the pharmaceutical industry has greatly overtaken the defense industry in recent years. The pharmaceutical industry now tops not only the defense industry, but all other industries in the total amount of fraud payments for actions against the federal government under the False Claims Act.”

The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects. Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments.

The rapidly rising number of criminal and civil penalties against Big Pharm in recent years have been described as a “veritable crime spree.”

Hospital Hazards

November 26th, 2010

The New England Journal of Medicine  published this Thanksgiving week, a report showing the patient safety in hospitals has not improved over the years 2002-2007.  This despite the fact the study was conducted in North Carolina whose hospitals, compare favorably with other states and where the hospitals have been more involved in programs to improve patient safety. Harm to patients was common and the number of incidents did not decrease over time. The most common problems were complications from procedures or drugs and hospital-acquired infections.

Among the preventable problems that Dr. Landrigan’s, a Harvard Professor and his team identified, were severe bleeding during an operation, serious breathing trouble caused by a procedure that was performed incorrectly, a fall causing dislocation or hip fracture,  and vaginal injuries caused by a vacuum device used in some deliveries.

As also described in the New York Times on Nov. 25 this is “one of the most rigorous  efforts to collect data about patient safety since a landmark report in 1999.”  That widely quoted report by the Institute of Medicine, an independent group that advises the government on health matters, found that medical mistakes caused as many as 98,000 deaths and more than one million injuries a year in the United Stat

The Harvard researchers found a high rate of problems. About 18% of patients were harmed by medical care, some more than once, and 63%  of the injuries were judged to be preventable.  In 2.4%  of cases the problems caused or contributed to the patient’s death.

A recent government report found similar shocking findings.  In October 2008, 13.5 percent of Medicare beneficiaries — 134,000 patients — experienced “adverse events” during hospital stays. In 7% of these patients   medical mistakes contributed to their deaths. That report, was issued this month (Nov. 2010) by Department of Health and Human Services.

Dr. Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — not named-in both urban and rural areas and involving large and small medical centers. The researchers used a list of  red flags to pinpoint possible problems.  They included drugs used only to reverse an overdose, the presence of bedsores or the patient’s readmission to the hospital within 30 days.

The researchers found 588 instances in which a patient was harmed by medical care, or 25  injuries per 100 admissions!

This is most likely the tip of the iceberg of medical injuries resulting from hospital “care.” How many injuries and deaths due to mistakes, misadventures, medical errors, and other causes occur outside of hospitals? Will we ever know?

Avandia Demoted

October 29th, 2010

трапезни масиAvandia, was first approved in May 1999 by the FDA for  the treatment of Type II (noninsulin-dependent) diabetes, and up to recently was one of the most prescribed drug for this condition.  At the time of approval, Dr. Steven Nissen, a Cleveland Clinic cardiologist whose studies identified Avandia’s heart attack risks, said that the decision brought an end to “one of the worst drug safety tragedies in our lifetime,” adding that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.” This  “regulatory process” has been going on for 11 years, since Avandia was introduced in 1999.

One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.

The decision,  on Avandia was reported in the New York Times . Because of Avandia, the F.D.A. announced in 2008 that it would no longer approve medicines simply because they help diabetics control blood sugar levels — the standard for more than 80 years.  Instead, the F.D.A. now insists that drugmakers conduct trials lasting at least two years to show that their drugs do not hurt the heart and that they improve the quality or length of diabetics’ lives, far tougher tests.

The Avandia story also begins a new and unsettling period for pharmaceutical companies because Avandia’s risks became known well before FDA approval after Dr. Nissen analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its Web site as a result of a legal settlement. Such public postings  mean that drugmakers can no longer easily hide or control scientific information about their medicines.

The agency’s decision to order restrictions on Avandia’s sales also demonstrates that the F.D.A. — given new powers over drugmakers and drug distribution in a 2007 law — intends to use those powers-three years later! The agency has now ordered that dozens of drugs be sold only with special restrictions.

Dr. Janet Woodcock, director of the F.D.A.’s drug center said, “We know that labels are often not read.” It was an extraordinary acknowledgment from a veteran of an agency that has relied for decades on label warnings to control drug use.

The suspension and restrictions all but ensure that Avandia’s sales — $1.19 billion last year and $3.2 billion as recently as 2006  should plunge. The drug has already been banned in the European Union.  Avandia was once the biggest-selling diabetes drug around the world, despite the fact that there are over 117  other drugs available to treat type II diabetes. There were 600,000 people taking Avandia in the United States a few months ago.

GlaxoSmithKline responded that “the company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes” and is working with the F.D.A. and European regulators “to implement the required actions.” The company promised that it would end Avandia promotions around the world.

The restrictions will take months to put in place. Patients now taking Avandia should continue to do so until they can consult their doctors, said Dr. Joshua Sharfstein, the F.D.A.’s principal deputy commissioner. ” WHAT?
But he said that doctors should now consider switching patients to other medicines.

FLASH: GlaxoSmithKline, the British drug giant, has recently agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

Question: Is there too much pressure from Big Pharm and Glaxo and its stockholders to take Avandia off the market as they did in Europe? The FDA is still giving excuses.