Archive for the ‘Uncategorized’ Category

Avandia Demoted

Friday, 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.

Sports Doping

Wednesday, February 11th, 2009

Poor Alex Rodriguez, hounded, castigated, dragged through the media mud, even brought up at President Obama’s first news conference. Then there’s the lingering Barry Bonds story, (4.33 million hits on Google). Poor Bonds who faces 10 counts of perjury and one of obstructing justice, has been the subject of investigation since 2003, for lying about taking steroids. Too bad he hit so many home runs. Then, there’s the wheels coming off the Tour de France every summer as juiced up cyclists keep getting dismissed for doping, the NFL story, the NBA, and the college sports scandals, etc.

The sports lawyer Michelle Gallen has said that the pursuit of doping athletes has turned into a modern day witch hunt.  It also seems like a repellent media circus.

Here’s a modest proposal I’ve made before in one of my newsletters, not all tongue in cheek: Wouldn’t it be nice if we had a two-tier level of sports competition, one for the performance enhanced, the dopers, the other for the “straights” who reject drug use? Obviously there would be logistics problems since you’d have to test everyone; how many positive or negative tests would get you out-or in- of the “straights”? As I observed, advantages for the athletes would be clear: competitive fairness, and no pressure to risk life and liver for fear of losing fame, paycheck and endorsements-and perhaps going to jail for lying.

For the rest of us sports lovers, think of the enormous economic and social benefits: Two NFL’s two NBA’s, six baseball divisions, another Tour de France, even two world Olympics, two Wimbledons, etc.  Multiply all the games in all the sports by two, and you could have:  Twice as many opportunities for aspiring athletes, twice as much ad and product revenue, double the number of fans and stadiums.  Then there’s the amplified media coverage, more TV sports channels, more jobs for sports writers, though a downside for lawyers and the judiciary. Who knows, it may save endangered segments of the media industry, especially advertising,  newspapers and local TV.

Last but not least, a double tiered sports culture might, by enhancing economic activity, help pay off the Troubled Asset Relief Program and and some of the other economic stimuli up the sleeves of our legislators.  We might even experience a rise of the S&P 500, if not the Dow Jones.

The FDA and Us

Friday, February 22nd, 2008

The National Academy of Science’s Institute of Medicine, the Government Accountability Office, and the F.D.A.’s own science board, along with numerous independent groups have raised serious questions over the effectiveness and competence of the Food and Drug Administration. Specifically, these Government agencies have all issued reports concluding as reported in the New York Times “that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices, and (even) food.”

For the first 86 years of FDA’s existence, from 1906-1992, all of its funding came through the U.S. Treasury. In other words, industry and the public paid their taxes, and FDA got appropriations out of the budget. If the FDA made a mistake, many of which occurred over the years, there would be a congressional hearing. The Agency would be accountable to the public through the legislative branch and explain what went wrong and why.

In 1992, unfortunately, the entire regulatory landscape was changed profoundly as the result of a new law which was passed. The law required that much of the cost expended by the FDA on new drug applications would come directly from industry. In other words, to get a drug or device reviewed, the manufacturer would pay directly to the FDA. To understand how this legislation created a cozy relationship between industry and the Agency that regulates it, see this interesting interview. There it is explained why we are seeing an explosion in class action lawsuits against drug companies, the results of “fast track approvals” and increasing numbers of new drugs and devices being withdrawn from the market.

Casualties of War: Untold Story

Monday, February 4th, 2008

According to internal Army documents, reported in previous years, and yesterday again by CNN, the number of attempted suicides or self-inflicted injuries in U.S active duty soldiers is rising at an alarming rate. This figures, derived principally from those serving in or returning from Iraq and Afghanistan, have gone from approximately 350 in 2002 to more than 2,100 last year (2007). The number of suicides among active military service members, reached their highest level since the Army began keeping such records in 1980, 121 suicides in 2007, 20% higher than in the previous year.

Casualty, defined by Webster’s is “a military person lost through death, wounds, injury, sickness, internment, or capture or through being missing in action” or, “b: a person or thing injured, lost, or destroyed.” Casualty figures for U.S. and coalition forces, both civilian and military in Afghanistan and Iraq are reported at this site. American deaths in Iraq now approach 4,000 since the war began, with over 50,000 serious injuries, including over 8,000 severe limb injuries and estimated amputations, anywhere from 423 to almost 1,000 in other reports. Iraqi civilian deaths have been estimated at over 100,000 and total casualties over 832,00 since the U.S. invasion.

A Math Story for Professionals

Sunday, December 30th, 2007

Once upon a time in Futureland when TV celebrity and talk shows, sports events, and sitcoms were hemorrhaging viewers, giant sponsored colloquia were held to discuss various philosophical issues. These were broadcast on world wide television in 75 languages and viewed by 1.3-2.4 billion people every other night. One such seminar originating on a Swiss mountaintop dealt with a vexing international question: “What are two plus two?” Present were important world class experts from diverse disciplines.

When first asked, “What is the sum of two plus two?” the mathematician quickly answered, “four.”

Next in turn was the physicist who replied, “in the neighborhood of four.”

The engineer responded with, “four point zero, zero, zero plus or minus zero.”

The economist without hesitation concluded, “two plus two are seven.”

Next was the lawyer’s turn. He looked at the host and asked, “Could you repeat the question?” After it was again posed, the lawyer pondered a moment, shrugged his shoulders, and inquired, “What would you like?”

Finally, it was the physician’s opportunity. He slowly repeated the question over and over again. Finally his eyes brightened, he smiled and announced, “Let’s order some tests.”

Happy and Disease-Free New Years to All.

Early Experiences of a Medical Blogger

Monday, August 27th, 2007

After I announced: We welcome appropriate comments, all of which must include your e-mail address. Back links masquerading as comments will not be published, I was naive enough to think that would eliminate spammers attempting to infiltrate. It’s getting worse, of course. Mercury Is rising. There are currently 13 posts and 14 comments, contained within 4 categories. If I have to spend 15 minutes a day deleting junk mail that’s attempting to set a link, it’s still worth it.

Mostly, the blogs have been fun, but it seems that Vitamin C is still the hottest medical issue among the various topics covered, so at least one article struck a nerve. As for the lack of comments on the other nine posts, we’ll have to wait and see. Would you like the posts to be shorter?

Any comments on these comments?

On Being a Smart Patient

Friday, July 20th, 2007

There are many obvious and not-so-obvious questions you should ask yourself as well as your doctor when you consult her:

1. Is it difficult to get an appointment or reach my doctor in an emergency? Does the office have a convoluted automated call system, does my doctor return calls or do I hear from the office nurse or secretary? Is it difficult to get prescriptions re-filled?

2. When I have a physical complaint like back, muscle, or chest pain, does he/she examine me? If I have abdominal pain does she examine my abdomen while I’m lying recumbent on an examining table-and with my belly exposed. With new or unexplained abdominal pain, does she do a rectal or pelvic examination. (Which reminds me of a long-ignored surgical adage from my old friend, Dr. Goodman: “Put your finger in it before you put your foot in it.”)

3. Does my doctor encourage specialty consultation in serious, chronic, or unexplained illness, or am I reluctant or embarrassed to ask for an outside opinion?

As I have previously pointed out, it has long been accepted knowledge that an office visit generally concludes in one of three ways: the patient receives a prescription, an order for some tests-or both. With a new or chronic complaint, does the doctor rattle off a list of possible diagnoses. Beware the Rule-Out doctor. Patients, laboring under a sense of entitlement because they pay so much for health care, often are only too willing to collaborate in this clinical farce. One of our friends once remarked, “Why not get all the tests possible, check everything out, go for broke? It’s already paid for.” (By whom, I might I add? She was a nurse too.)

The idea that generally the more tests the better is a supreme example of deeply flawed thinking or clinical inexperience. Misguided, excessive medical investigation often discloses an innocent abnormality which far too often catalyzes an uncontrollable series of unforeseen events leading to clinical catastrophe, the so-called “cascade effect” (about which more later.) Moreover, unnecessary and redundant medical testing is one of the principal reasons our healthcare system is lurching into bankruptcy.

A critical consideration in ALL medical testing: Will the results of this test change my treatment? No medical test or procedure should be performed as a fishing expedition or for mere curiosity, but only for the purpose of changing the management of the patient. This is especially important with invasive testing, such as endoscopic studies or cardiac catheterization, all of which carry minute but measureable risks of misadventure.

Seat Belts, Airbags, and the Governor

Thursday, July 12th, 2007

It seems Chris Moltisante of The Sopranos prefigured another New Jersey accident by suffering multiple broken ribs and punctured lungs after not wearing his seat belt on one of the last TV shows of the series.”Typical injury from airbag” someone remarked. From the looks of Chris, blood pouring out of his mouth amid gasps for breath, he probably would have died anyway, but for the sake of the story, got a suffocation assist from Uncle Tony.

On April 12 this year New Jersey Governor Jon Corzine himself almost died of 11 broken ribs, and multiple other fractures when the SUV in which he was riding swerved to avoid another vehicle on the Garden State Parkway and crashed into a guardrail. His car, headed for a meeting with Don Imus and the Rutgers University women’s basketball team, was traveling at 91 mph, but none of the other four passengers, reportedly all wearing seat belts, suffered significant injury. Corzine was on a respirator and virtual life support for over a week, but miraculously survived. It should be noted that the Governor, in one story suggested he almost never used seat belts, even though failing to do so is against the law in most states, including New Jersey, which has one of the highest rates of seat belt use.

After his recovery, Mr. Corzine made a public apology along with a plea for the use of seat belts. “I’m New Jersey Governor Jon Corzine and I should be dead….I have to live with my mistake. You don’t. Buckle up.”

Let me pose a question: if you could only have one or the other, would you go for the seat belt or the air bag? The answer is easy. Don’t depend on air bags. Steven Levitt, co-author of Freakonomics, and Jack Porter, a professor at Wisconsin, wrote an article six years ago that compares the effectiveness of seat belts and air bags for adults. They found that “…wearing a seat belt reduced the chance of death by 60-70 percent across all crashes. We estimated that air bags reduce the death rate by 15 percent in frontal crashes, but did not help in partial frontal, side, or rear crashes. ” Previous research studies found benefits for adults even higher with seat belts, and lower than air bags! No one but a fool, who knows the data would prefer an airbag to a seat belt if it was an either/or choice. By their estimates to save a life with a seat belt costs $30,000; to save a life with an air bag costs $1.8 mm. See here.

Levitt suggested that one thing left out of the statistics is that airbags reduce the number of suicide attempts from running into trees and bridge abutments, “especially suicide attempts by people who want their deaths to appear to be accidents, for insurance purposes.”

Why Another Medical Blog?

Wednesday, July 11th, 2007

As my medical newsletter, Second Opinions, became more and more popular, it occurred to me that a blog might stimulate more frequent Internet postings, not only by me, but hopefully by readers as well.

Not that we are short of medical information or sources thereof. Just Google “chest pain” for over 3 million URL’s (or “Yahoo” Yahoo for over 16 million.) But information, is not always the equivalent of knowledge any more than widely-shared beliefs necessarily represent wisdom, let alone “truth. ”

That’s why second or third opinions may often be a reasonable approach, to be sought equally by the troubled patient as well as exhausted Internet searchers. If you want bland medical consensus, stop here. If you like medical news, filtered and unfiltered, and comments with a seasoning of controversy or criticism, read on. As Santayana once said, “Skepticism is the chastity of the mind; do not surrender it to the first comer.”