EasyDiagnosis Second Opinions

Откъде да купя иконаХудожникIt’s obvious now that daily aspirin is not for everyone.  The latest numbers indicate that about a third of middle-aged Americans take a daily baby aspirin (81 mg.)  in the belief that it will forestall a heart attack or reduce cancer risk.  Last month, January 2012, researchers in London analyzed nine randomized studies of aspirin in use in the U.S., Europe, and Japan that included 100,000 subjects who had never had  a heart attack or stroke.. Studies were reported in the Archives of Internal Medicine.

During a mean follow-up of 6.0 years (S.D. 2 years) aspirin treatment reduced total heart attacks (cardiovascular events) by 10% with no significant reduction in CVD death or cancer mortality, but there was increased risk of significant (“nontrivial”) bleeding, such as hemorrhagic strokes and particularly from ulcers of 30% -including yours truly!

Despite these reductions in nonfatal heart attacks (MI), the article’s  Conclusion continues: ” …aspirin prophylaxis in people without prior CVD does not lead to reductions in either cardiovascular death or cancer mortality. Because the benefits are futher offset by clinically important bleeding events, routine use of aspirin for primary prevention is not warranted and treatment decisions need to be considered on a case-case-basis.”

Yet, it continues to be a widespread practice by an ill-informed public to take a daily baby 81mg. aspirin or even half an adult aspirin, 160 mg. in the belief that it prevents heart attacks.  Bayer continues to advertise the illusory benefits, but not the risks of taking aspirin.

“A blanket recommendation that everybody should take an aspirin is not a good idea” Dr. Michael LeFevre of the government-backed U.S. Preventive Services Task Force told Reuters Health last year.  He added that the drug is probably overused by healthy people.

The task force currently advises that men age 45 to 79 take aspirin to stave off heart attacks as long as the benefit outweighs the risk of bleeding. For women age 55 to 79, the medication is recommended to prevent strokes, with the same caveat. This blunt advice was questioned by a reporter , Frederik Joevling who went ahead and questioned the CDC asking the press officer if the agency is now broadly promoting aspirin to healthy people. Here’s what followed:

“We generally recommend this,” he told me, “but always include a caveat to include an ability to take aspirin as well as to consult your healthcare provider.”  When pressed, the press officer referred Joevling to Dr. Janet Wright, the executive director of the CDC’s Million Hearts Initiative. “In a phone interview, she readily acknowledged that the email was wrong and that she hadn’t seen it before it went out.  Frankly, the aspirin thing can be so confusing to people,” Wright told Joevling.  “I’m so glad you were a filter before this got out.”

“That’s debatable; presumably, I was just one of many journalists who got the CDC’s Million Hearts pitch.”

There’s more. see the above link to Reuters and Mr. Joevling.

ikoniFive percent of  the U.S. population account for almost 50% of health care spending. In 2009, spending on health care in the U.S. reached $2.5 trillion, or $8,100 per person, and 17.6 percent of GDP.

Higher spending for hospital care and physician and clinical services accounted for half of the increase in total national health spending between 2005 and 2009 and more than 80 percent of the increase in private insurance premiums over the period.
Source: National Institute for Health Care Management Foundation (NIHCM)

A survey of more than 1,200 seniors revealed that, due to costs:
* 51% of respondents put off visiting a doctor or getting outpatient medical services
* 61% of respondents postponed visits to dentists, opticians, or hearing specialist
* 44% of respondents postponed filling prescriptions or chose to take a lower dosage than prescribed

* In addition, 44% of seniors are spending at least $300 per month in out-of-pocket medical expenses and 10% are spending at least $750 per month.

Moreover, spending for Medicaid projected to increase 28.7 percent. According to a new survey by Kaiser, Medicaid officials in virtually every state are enacting a variety of cost cutting measures. The substantial but temporary increase in the federal share of Medicaid spending brought about the only declines in state spending on Medicaid  even as the deep recession sharply increased Medicaid enrollment and overall Medicaid spending during that period. With that money having expired in June 2011, however, states must ramp up their own spending to replace the lost funds.

Source:  Kaiser Family Foundation. October 27, 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.

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.
__________________________________

Here are a few specifics to ponder. Under the present Act  passed last year in March:

32 million uninsured Americans will gain access to health coverage.

Insurers will no longer be allowed to deny coverage to patients based on pre-existing conditions, and patients will no longer face lifetime caps on coverage or be threatened with cancellation of coverage.

Children can remain on their parents’ policies until the age of 26.

Competition will enter the insurance marketplace since health insurance exchanges and co-ops will be created allowing pooling of coverage for individuals and small businesses. High risk insurance pools will be created.

The bill leaves medical decisions in the hands of you and your doctor. Subsidies will help low-income individuals and families buy health insurance.

Immediate tax credits will be extended to small businesses for purchase of health insurance for employees.

Insurance claims processing will be standardized and streamlined, helping lower health provider overhead costs.

The widely despised Medicare Part D Coverage Gap (donut hole) that haunts millions of seniors will be closed.

According to estimates by the Congressional Budget Office, the new bill will keep Medicare financially sound for 10 years by cutting rates of increase in health care costs. This should help cut the U.S. deficit by $143 billion.

These are the facts. Can some readers give me convincing reasons this first new health bill in over 50 years, should be the subject of political attack and face the danger of emasculation if not legislative annihilation?

And now they want to turn Medicare over to the insurance companies!

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

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.”

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?

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.