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.

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.

Truth and Untruth in Drug Trials

September 2nd, 2010

There are three types of mendacity in the world, lies, damn lies and statistics.

– Mark Twain

The Food and Drug Administration (FDA) maintains a large, but incomplete repository of randomized controlled trials (RCT) as part of its new drug application process. Before  conducting new drug application trials, pharmaceutical companies must register them with the FDA. This registration includes pre-specifying various outcome measures and analytic methods. Pre-specification is supposed to ensure the integrity of a trial, but there is a catch-22 here. What if the investigators already have an idea-or prior knowledge of some trial results? This is a form of research bias know as HARKing or “hypothesizing after the results are known”, an open invitation for audacious cheating.

Key findings in a recently published combined (meta)-analysis (see (Psychother Psychosom. 2010;79:267) compared all trials for new drugs approved by the FDA from 2001 to 2002 with publication status of these trials 5 years later. The authors found:

New drug application studies with favorable outcomes were almost five times more likely to be published as those with unfavorable ones. 26.5% of pre-specified primary outcome measures were omitted from journal articles of new drug trials. Of the 43 primary measures not supporting efficacy, 20 (47%) were not included in the published results.

The analysis of these articles, in other words, showed significant “publication bias,” HARKing, in other words, a nice way of describing research inflating the apparent effectiveness of new drugs.  Is cherry picking the results of drug trials simply a form of lying? Or did I use a dirty word?

Who’s Against Embryos?

August 24th, 2010

“A misdirected zeal in matters of religion befogs the truth most grievously.”

Charles Mackay

Same old story, might as well call any cell in the body an embryonic stem cell, for what the old laws are hoping to accomplish. We’re back in the midst of theological dysfunction now with a Federal District Judge, Roce C. Lambert ruling that President Obama’s 2009 executive order that expanded embryonic stem cell research  violated a ban on federal money being used to destroy embryos.Of course, private industry can still invest in this area, but massive Federal money for supporting this vital research which may ultimately pave the way to success from everything for organ replacement to a cure for Alzheimer’s, is for the moment at least, dead in the water.  The decision of Judge Lambert, originally appointed by Reagan, means that the health institutes had to resume using harsh Bush administration rules for future grants.

Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital, Boston , referring to culture fluid given to cells, said, “This ruling means an immediate disruption of dozens of labs doing this work since the Obama administration made its order.”

Stay tuned.

Avandia Back in the News

June 29th, 2010

CBS Evening News (6/28, story 10, 0:30, Smith) reported FDA experts meet in two weeks to decide whether or not to pull Avandia (GlaxoSmithKline) off the market, while Brian Williams of NBC News also reported yesterday (June 28,3010) , however, that the drug’s maker, GlaxoSmithKline, “said today the drug is effective and safe.” The drug (Rosiglitazone) is still used for millions of patients with type II diabetes, although several other drugs are available for treatment of the condition.The drug was linked to 304 deaths in the third quarter of last year.

Yet, three years ago in May 2007, and followed by many other reports, Avandia was linked to a 43 percent greater risk of heart attack and death in a study published by the New England Journal. See this link.The FDA is still in a bind despite a recommendation last February that the drug be taken off the market. (Supposedly) when a drug maker refuses to pull a potentially fatal medication off the market, the FDA, believe it or not, does not necessarily have the authority to force a recall. “In the interests of free commerce” (see link above), though The FDA has authority to force a black box warning be placed on the drug, the Agency does not have explicit power to force a company to remove the drug from the market. According to the above link “As long as the risks and benefits of a drug are fully disclosed to a patient and the patient voluntarily consents to its use, the FDA has no power to interfere in that patient’s treatment.”Stay tuned.

WHO Still thinks it’s a Pandemic

June 7th, 2010

According to the AMA Morning Rounds, World Health Organization (WHO) official still insist that the swine flu, H1N1 continues to be a “pandemic,” even though the period of most intense activity appears to have passed. The June 3 announcement came two days after a virtual meeting of international flu experts who advise Director-General Margaret Chan “on setting the global body’s pandemic alert level.”

This was surprising to many observers, because they “had expected the 15-member committee of experts, whose members are anonymous, to declare that the pandemic was in its ‘post-peak’ phase, or even in its ‘post-pandemic’ phase, which would mean that the pandemic was over.” But, Dr. Chan quickly pointed out that while “‘the period of most intense pandemic appears likely to have passed for many parts of the world,’ activity is continuing in some areas (Cuba, Central America) and many people remain vulnerable.”See my blog of Jan.26  and comments by Dr. Wolfgang Wodarg, chairman of the Parliamentary Assembly of the Council of Europe (PACE) Health Committee, cited previously, whom I quoted, “The WHO’s “false pandemic” flu campaign is “one of the greatest medicine scandals of the century.” Dr. Wodarg introduced the parliamentary motion to hold an emergency debate and inquiry into the “influence” exerted by the pharmaceutical industry on the World Health Organization’s (WHO) global H1N1 flu campaign.  “The definition of an alarming pandemic must not be under the influence of drug-sellers,” he added.

Xenical-Liver Risks Reported

May 27th, 2010

Orlistat (Xenical), used as a weight loss drug, is notorious for its gastrointestinal side effects- described as “treatment effects”, which can include steatorrhea  (oily, loose stools), since it inhibits the digestion of fat. The drug, which appeared to be safe for long-term use-don’t all drugs?-is available without prescription in the United States, the European Union, and Australia. Over-the-counter approval was controversial in the United States with consumer advocacy group, Public Citizen repeatedly opposing it on safety and efficacy grounds.

The AMA in its “Morning Rounds” reports the FDA is now requiring a liver-injury warning label, after receiving reports of liver damage by patients on this wildly popular diet drug.  (ABC World News 5/26, story 8, 0:20, Diane Sawyer.) The drug has been taken by nearly 40 million people.

The FDA has decided to put the new warning on Xenical (orlistat), developed by Roche’s Genentech, and its over-the-counter version,”Alli,” which is manufactured by GlaxoSmithKline (GSK).  To date, the agency has identified 32 cases of severe liver damage hepatocellular necrosis or acute hepatic failure, 2 of them outside the US.

Now, the revised label for orlistat (Xenical) will include new safety information about rare cases of severe liver injury. The agency stated, however, that “it has not yet established a causal relationship between orlistat use and severe liver injury.” For instance, some of the patients in question were taking other drugs while using the diet medications, others may have had conditions that exacerbated their liver disease.

Still, HealthDay (5/26, Gardner) reported, the agency is “‘telling consumers and healthcare providers to be vigilant should patients develop symptoms suggestive of liver impairment,” said FDA spokeswoman Elaine Gansz Bobo. She added, “We are not advising routine monitoring of liver enzymes as that will not help predict who may develop hepatic impairment on the drug.” People taking Orlistat — the active ingredient in both drugs — were warned to be on the lookout for itching, yellow eyes or skin, dark urine and loss of appetite, all of which are symptoms of liver problems.

If history is any guide, many more cases of serious liver problems will emerge in future.  The true extent of most drug reactions, serious, and not-so-serious-take years to come to the attention of the authorities and the public before proper warnings are issued or the offending drug is taken off the market.

Probable Dangers of Proton Pump Inhibitors (PPI’a)

May 20th, 2010

Proton pump inhibitors (PPIs) are among the most popular drugs used to treat acid reflux and ulcers. They are sold under brand names like Nexium (the famous “purple pill”), Prilosec and Prevacid, and generate “$13.5 billion in sales. In 2009, approximately 119 million PPI prescriptions were written in the US, making the medicines part of the third-largest selling class of drugs. The six available PPI medicines are roughly equal in effectiveness and safety but differ markedly in cost. Two—omeprazole (Prilosec, Prilosec OTC) and lansoprazole (Prevacid,)—are available as both a prescription and a nonprescription drug. Taking effectiveness, safety, cost, and other factors into account, if you need a PPI,  consider following Consumer Reports Best Buy Drugs:live streaming film Straight Outta Compton online

■ Prilosec OTC
■ Generic omeprazole OTC

Both of these drugs are available without a prescription. You could save about $200 a month or more by choosing one of these drugs over a more expensive medication listed above. See this informative report.

Unfortunately, like all drugs, PPI’s have problems. The Wall Street Journal reviews several recent reports from the medical literature about complications, and CNN  reported on its website that medical experts claim the risks of taking PPIs may outweigh the benefits for people with less serious conditions. PPI’s can have rare but serious side effects, including an increased risk of GI bacterial infection and bone fracture, according to several new studies in the Archives of Internal Medicine.  Over prescribing these drugs for simple heartburn or dyspepsia has become almost reflexive.

The Boston Globe (5/10, Cooney) “WhiteCoat Notes” blog reported that patients on PPI’s had a 47 percent increased risk of spine fractures, a 26 percent increased risk of forearm or wrist fractures, and a 25 percent increased risk of other fractures.”

Doctors at the Beth Israel Deaconess Medical Center in Boston, analyzed data on more than 100,000 patients discharged from the hospital over a five-year period, HealthDay (5/10, Goodwin). They found that taking a proton pump inhibitor each day increased the chances of a serious diarrheal disease, C. difficile infection by 74 percent,” and “patients who took proton pump inhibitors longer than that had more than double the chance.”

Five years ago, I wrote that “the oldest and still the most widely used first line drugs for heartburn and dyspeptic symptoms are the antacids, such as Tums, Maalox, Mylanta, Rolaids, etc. These have the advantage of rapid relief in most patients, and low price. …With GERD and ulcer, the H2-receptor antagonists, Zantac (ranitidine), Pepcid (famotidine), and Tagamet (cimetidine), etc. are in most cases as effective as the PPI’s.

“Proton pump inhibitors are often over prescribed in long-term care, disregarding published guidelines for their use..”  It is interesting to note that PPI’s are not approved for treatment of simple dyspepsia or uncomplicated heartburn.