COURT FINDS AGAINST DRUG COMPANIES IN MEDICAID OVERCHARGE PRICING SCHEME

For the second time this year, the State of Alabama has won a significant victory in court against powerful drug companies. This time, the litigation involved GlaxoSmithKline and Novartis Pharmaceuticals Corp and with the court awarding a total of $114,247,233 to the state. Earlier this year, the state was awarded a $215 million verdict against the AstraZeneca Pharmaceutical Company.

State Attorney General Troy King initiated legislation against the drug giants for massive overcharges to the Alabama Medicaid Agency. According to the state, both companies overcharged Medicaid for drugs from 1991 to 2005. The companies had allegedly charged the state more for medications than they did other customers. This is against the law as Medicaid is to be charged the drug maker’s lowest offered prices. The state initially sought $800 million in settlement.

“The people of Alabama can be reassured that grave injustices are being made right and that public funds taken by corporate manipulation schemes are being recovered,” said the attorney general. He went on to say that the state will, “hold accountable anyone, no matter how powerful and wealthy, who would take advantage our state and our citizens.”

These cases being tried in Alabama for overcharges to the Alabama Medicaid Agency have become known as “average wholesale pricing” (AWP) cases. The state contends that the pharmaceutical companies misreported and then inflated the prices they charged for prescription drugs resulting in a scheme to overcharge Medicaid. Earlier this year the attorney general filed lawsuits against 79 companies for their participation in this AWP scheme.

The first court award from these lawsuits went against AstraZeneca for a total of $215 million. A judge later reduced the award to a still substantial amount of $160 million. In this current suit, GlaxoSmithKline is to pay $80,989,539 with Novartis to pay $33,257,694.

The attorney general seemed pleased with the court’s decision. “The State of Alabama continues to achieve victories in the important work of recovering what has been stolen from the Alabama Medicaid Agency and those who depend upon that agency for their needed medicines,” he said.

Source: The State of Alabama Office of the Attorney General. “A.G. Announces Second Victory in Drug Pricing Lawsuit.” Press Release. July 2008.

http://www.ago.state.al.us/news_template.cfm?Item=1192

SURGICAL CHECKLIST MAY SAVE LIVES

The World Health Organization (WHO) is finding it necessary to get into the business of trying to make medical surgery a safer happening. According to WHO, some 234 million surgeries are performed globally each year.

This breaks down to about 1 surgery for every 25 people. With studies showing that a significant percentage of surgical procedures result in preventable complications or death, WHO is launching a new safety checklist for surgical teams to use in a major attempt to make surgeries safer everywhere in the world.

The initiative sponsored by WHO is known as Safe Surgery Saves Lives and is done jointly with the Harvard School of Public Health. The surgical safety checklist provided by WHO as part of this program has identified and implemented a set of surgical safety standards that can be utilized in all counties of the world and in all healthcare settings.

This appears to be a much needed measure for the medical community. According to several studies utilized by WHO, major complications from surgery occur in industrial countries in between 3 and 16 percent of inpatient surgical procedures. Permanent disability and death rates are about 0.4 to 0.8 percent. The death rate soars in developing countries to between 5 and 10 percent during major operations. In addition, post operative complications are also a major occurrence and a source of serious concern all around the world. Studies suggest that about half of these types of complications can be prevented, according to WHO.

Three phases of an operation receive focus on the checklist. These are “sign in” before anesthesia is introduced, “time out” before an incision is made”, and “sign out” before the patient leaves the operating room. “Sign in” would include marking the correct part of the body for surgery and checking on allergy conditions of the patient. “Sign out” would included checking to see that all surgical instruments, sponges and needles are accounted for and not left inside the patient’s body.

A pilot program conducted on 1,000 patients at 8 different sites indicates a doubled likelihood that the patient will receive higher, proven standards of care. While the final results are not yet in, WHO says that the complication and death rate in these 1,000 patients shows substantial reductions from the current norm.

The amount of people in the United States alone who die annually due to medical error is slated at about 98,000. If a substantial number of these can be reduced by the WHO checklist, it behooves every hospital, surgical unit and medical provider to implement the procedures as quickly as possible.

Source: The World Health Organization. “New Checklist to Help Make Surgery Safer.” Press Release. June 2005 http://www.who.int/mediacentre/news/releases/2008/pr20/en/index.html

SURGERY ON THE WRONG LUNG BRINGS LICENSE SUSPENSION TO M.D.

A New Jersey doctor has had his license suspended for operating on the wrong lung and then for trying to conceal his error in an attempt to deceive his patient. The matter was brought to the attention of the New Jersey State Board of Medical Examiners after Santusht Perera M.D. removed a portion of his patient’s right lung when he should have been operating on the left lung. According to board proceedings, the patient’s lung contained a tumor that was slated for an operation to be conducted by Dr. Perera.

As a result of the Board of Examiners’ investigation, Dr. Perera’s medical license has been suspended for 2 years. In addition, he was fined $30,000 as a civil penalty and reimbursement costs totaling $51,273.10.

“The tragic error which occurred in this case could have been prevented had Dr. Perera simply engaged in the most basic and minimal of actions that should be taken by a surgeon in advance of surgery,” according the Board of Examiners. “We find his failure to have taken those basic actions unquestionably constituted gross negligence.”

As if it wasn’t bad enough that the surgical error occurred, Dr. Perera also attempted to conceal this negligence from his patient. Following the surgery, Dr. Perera told his patient that the right portion of the lung he removed in error contained a life-threatening tumor even though he knew that this was not true. The board also found that Dr. Perera went so far as to alter his office records to show that he intended to operate on the right lung when he was really trying to remove a tumor that was in the left lung.

David Szuchman, Consumer Affairs Director for the State of New Jersey had this to say, “As horrific as the removal of the wrong lung is, the attempted deceit is disturbing in and of itself. Patients must have trust in their physicians and Dr. Perera obviously violated that trust.”

Dr. Perera responded to the board’s finding by filing an application in Appellate Court for a reversal of the decision. This petition was denied. At this point, the 2-year suspension with a minimum of 6 months of active suspension took effect on June 6. Dr. Perera practices medicine at the Hoboken University Medical Center.

Source: State of New Jersey Office of the Attorney General. “State Licensing Board Suspends License of Surgeon Who Removed Wrong Lung.”

Press Release. June 2008. http://www.nj.gov/oag/newsreleases08/pr20080625a.html

It’s a cover-up that happened almost 25 years ago, but it’s the thinking behind it and the ramifications of official actions at the time that still pervade the pharmaceutical industry today. Unfortunately, the organization that is supposed to protect Americans as well as other peoples of the world from injustices and harmful products at the hands of the drugproducing giants is apparently fully immersed in the scandal.

In the early 1980s, Bayer Corporation was involved in the production of Factor VIII, a drug that was used to treat hemophiliacs (a medical condition where the body has an inability to clot blood causing severe bleeding from even a minor injury), mostly children. Unfortunately, a large batch of this drug was contaminated by the HIV virus and was known to be tainted. These facts become widely known in the United States.

Seeing that their large investment in this drug was potentially going to be lost, Bayer officials came up with a solution. They sent this tainted product overseas to be marketed in countries where the news of Factor VIII contamination  had not yet spread. These areas included Spain and France in Europe, several countries in South America, as well as Japan.

Just as had occurred when the drug was in use in the United States, children in these countries began to develop the symptoms of HIV. In Hong Kong and Taiwan alone, it is estimated that over one hundred hemophiliacs contracted HIV after using the tainted medicine.

The problem with the drug came about when Bayer produced the drug-clotting medication using unheated blood concentrates. The drug is made by combining large stocks of blood plasmas collected from many donors. When some HIV tainted blood was included in the mix, the entire large batch was contaminated. After this was discovered, new stocks were subsequently made with heat-treated blood to eliminate the HIV threat.

That’s when the question of what to do with the entire tainted batch was addressed, and this is when the US Food and Drug Administration (FDA) got into the act. In a report of the story brought to light by the 

New York Times , it’s alleged that our own FDA officials recommended marketing the initial batch to countries that included Japan, Malaysia, Singapore, Indonesia and Argentina. In that manner, the company could still reap profits from sales even though Factor VII was pulled from the US market.

Despite the fact that at least two officials in France were subsequently sent to jail for approving the controversial drug in their country, the whole matter was kept under wraps in the US. Here, neither the FDA nor Bayer were subject to any investigation or indictment. The whole situation was handled quietly without alerting Congress, the medical community or the public. Of course, Bayer to this day maintains that the company behaved in a responsible and ethical manner.

For further information on this, take a look at a MSNBC video report on this incident entitled “Pharmaceutical Ethics: Protected by the White House, FDA and Congress,” and you can also visit:

http://www.brasschecktv.com/page/377.html. It’s a bit of an eye-opener!

Source: The Institute of Science in Society. “FDA in Third World Drug Trial Scandals. HIV Drug Dumped on Developing Countries.” January 2006. http://www.i-sis.org.uk:80/FDAinDrugTrial.php

FDA TO REQUIRE BOX WARNING FOR CIPRO® AND SIMILAR ANTIBIOTICS

It’s taken over 12 years since an original petition was filed, but the US Food and Drug Administration (FDA) is finally getting around to putting a Black Box Warning label on the antibiotic Cipro *

Back in 1996, the watchdog group Public Citizen initially presented evidence to the FDA in the form of a petition to require stronger warning labels for all drugs containing fluoroquinolone antibiotics due to reported increased risks of patients developing tendonitis or experiencing tendon rupture. These types of antibiotics are widely prescribed for gastrointestinal, respiratory and urinary infections. The FDA honored the 1996 petition, but warnings about the product were buried in a list of possible reactions and considered inadequate.

Public Citizen reviewed the FDA’s adverse events database form 1997 to 2005 and found enough evidence of tendon problems to submit another warning petition in 2005. During this period of time, there were 262 cases of tendon ruptures reported and over 500 cases of tendonitis and other tendon disorders. Ruptures of the Achilles tendon were the most sudden and severe. Other areas of the body affected include the rotator cuff, thebiceps, the hand and the thumb. (Tendons are tough fibrous tissue that connects muscles to joints.)

The reason that fluoroquinolone drugs affect the tendons in this manner is not completely known. One theory is that these antibiotics are toxic to tendon fibers and may cause a decrease in the blood supply to tendons, a part of the body that already operates on a limited blood supply.

The recent FDA action to raise the status of Cipro

Persons who are taking Cipro

Persons who are over 60 years of age are considered to be at higher risk of tendon-related problems. Also in the higher risk category is anyone taking steroids, as well as persons who have had organ transplants, according to the FDA.

The following list of medications are being targeted by the FDA for Black Box Warnings: Cipro® , Cipro XR ®, Proquiin XR®, Factive®, Levaquin®, Avelox®, Noroxin® and generic ofloxacin, also marketed as Floxin®.®  or other fluoroquinolone drugs should be instructed to stop taking them immediately if they develop tendon pain. Symptoms may include swelling, inflammation and tears of a tendon.®  to a Black Box Warning is the result of a suit filed against the FDA by Public Citizen for failing to honor petition requests from over 2 years ago. The FDA will now issue a notice to all manufacturers of fluoroquinolone drugs to add a boxed warning regarding the likelihood of developing tendonitis or experiencing tendon rupture. Manufacturers will also be directed to develop a “medication guide” for patients

and other similar antibiotics.

This August, the eyes of the world will turn to Beijing, China, where we will be treated to marvelous performances from the crème de la crème of the athletically trained world. We will marvel at their skill, be reminded frequently of their sacrifices and be totally impressed with their high level of conditioning.

Yet it is just this fashion of training regimen that lead to some severe health difficulties for one past Olympic-quality athlete. His name is Keith McCormick and he is a chiropractor, a member of the 1976 Olympic team and most recently a competitor in the 2005 Iron Man competition in Hawaii. In retrospect, it is his continued ability to be able to compete in Iron Man events that is most remarkable.

The reason is that 53-year-old Dr. McCormick suffers from osteoporosis. A number of years ago this worldclass athlete became aware of his condition. “I was an Iron Man competitor, Olympic athlete, a young male with no risk factors – not your typical osteoporosis patient. I was 45 and had the skeleton of a 100-year-old woman.”

A typical road to follow for anyone with this type of a diagnosis would be to take a drug for the problem. However, this avenue did not sit well with a man trained as a chiropractor with a much higher wellness approach to healing. “Anything I do, I go all out,” he said. “I’m not going to rely on someone else. They just wanted to give me medicine. I wanted to find out why this happened and fix it the right way.” Basically, he followed the age-old advice of “physician health thyself” and decided to do something positive about his condition.

What Dr. McCormick found through his extensive research that went on for some 2 years is that he was overtraining. For a 1982 Iron Man competition he averaged 35 hours per week of working out, which included 450 miles per week on his bicycle. It turned out that this was just too much work for his skeletal system to handle.

The result of his study was a new training schedule and just as importantly, a new diet. Armed with his new knowledge, he ate better and cut down on his workout time. “I rested more, and I had an impeccable diet – no sweets, lots of fruits and vegetables and nothing too high in protein which can lead to calcium loss. My whole way of attacking dietary nutrition was an aspect I paid more attention to. I realized it’s important that if I train I need to fill my cup afterward.”

This portrait of Dr. McCormick’s success in looking at his health situation and doing something about it is a scenario that all can benefit from – world class athlete or not. Whether you want to find out more for yourself or simply consult a chiropractor to put you onto a healthy lifestyle, the choice is yours. In the meantime, enjoy the Olympics, marvel at the athletic ability on display and see if you can pick up a few tips that might enhance your own health and well-being.

Source: Chiropractic Research. “Iron Man Chiropractor Beats Osteoporosis.” January 2006. http://www.chiropracticresearch.org

A growing number of chiropractors in the United States are answering a call to provide their services for free to returning veterans from Iraq and Afghanistan.

The idea for free services was initiated in April by a chiropractor in Houston, Texas, and promoted by the International Chiropractors Association (ICA). Very quickly, 70 chiropractors from around the U.S. volunteered their services to be part of the program and the list continues to grow.

Basically, participating chiropractors are volunteering their expertise to help returning veterans for free for a period of one year following their tour of duty. While a limited number of Chiropractic services are provided through the US Department of Defense, volunteers are able to provide immediate treatments. This brings quick relief to individuals who are either being rotated back to the U.S for stateside deployment or returning to civilian life.

Houston chiropractor, Richard J. Kelly is the initiator of what is becoming a nationwide effort to help returning members of our armed services. “Our military, our returning veterans, whether visibly wounded or free of outward symptoms, are coming home changed and need our help as chiropractors,” said Dr. Kelly. He began by offering his services to returning service people in his own practice. He found his work to be very positively received by the veterans as well as gratifying for him to provide.

One of the most common concerns expressed by returning veterans is lower back pain. This would be quite expected considering that ground force members in Iraq frequently carry over 100 pounds of equipment. One helicopter pilot who has done 2 tours of duty in Iraq had this to say about his symptoms. “I definitely have a lot of back pain, lower back especially, and neck pain was the biggest one I noticed.”

While any chiropractor can participate, the ICA is actively promoting the concept of free veterans care to its 8,000-some members. “We want to help volunteer doctors reach out to the returning veteran population in a spirit of service in the most clinically sound, ethically based and timely manner,” said Robert N. Pohtos who is the executive director of the ICA.

The services of a chiropractor often reach beyond the repair of physical injury to help a person restore their lives. What person needs this type of treatment and deserves it more than a veteran returning from the field of battle or who has faced the tribulations of war?

Source: The International Chiropractors Association, “Chiropractic Care for Returning Iraq and Afghanistan Veterans Now Available through Growing Volunteer

DC Network.” http://www.chiropractic.org/files/returning_vets_052708.pdf and Kid Chiropractic. “Chiropractors offer Free Care to Returning US Veterans.” www.kidchiropractic.com.

TRAVELING ENTERTAINERS, DANCERS TURN TO CHIROPRACTIC FOR TOP PERFORMANCE

Did you ever wonder how dancers and traveling entertainers are able to perform at a high physical level show after show? Don’t they suffer from things like sore knees, muscle pulls and sore backs? Toss in lots of late nights, brutal travel schedules and constant physical exertion and you have the formula for all sorts of health concerns.

Enter Chiropractic. One traveling children’s entertainment group from Australia known as 

“Nearly all of the 14 dancers on tour with The Wiggles  were suffering from shin splints, sore knees and hamstring problems from their grueling tour schedule,” said Anthony Field, a founder and original member of the group. This was before they came into contact with Dr. Stoxen. The Wiggles  are famous throughout Australia and are well-known in the United States as a highly interactive and energetic group of performers. They are known for their musical and dance productions, as well as a number of playful characters used to entertain and provide an educational message to children.

“The Wiggles have about 80 people on tour, only 15 of whom are performers. Any one of them could be experiencing health problems that need attention,” said Dr. Stoxen, who is known as a chiropractor to the stars. He is regularly on call to treat any number of performers or athletes who come through his home area of Chicago.

Field went on to talk about the reasons why members of 

Now, Dr. Stoxen is one of a number of chiropractors across the United States who has worked with

Sources: The Foundation for Chiropractic Progress. “On the Road with ‘The Wiggles’ and Other Celebrities.” Press Release. October 2007 http://www.f4cp.com/press_releases/index.htm and

Dynamic Chiropractic. “A Day in the Life of a Celebrity Chiropractor, Part I.” February 2008.The Wiggles. These performers have a great appreciation for Chiropractic and how the services of a chiropractor can help to keep them healthy and performing at the top of their ability.The Wiggles cast were coming down with injuries. “Many of their pains were due to lack of proper injury prevention exercises and poor dance performance footwear,” he said. Dr. Stoxen showed us exercises and the right footwear. Once the foot was right, the rest of our bodies were okay.”The Wiggles  has fully embraced Chiropractic as part of their routine. Members of the crew have been using Chiropractic going all the way back to 2004 when they enlisted the services of James Stoxen, DC.

LATEST ESTIMATE FOR MEDICAL ERRORS SETS

The latest medical error cost figures have just been released. Incredibly, the cost of potentially preventable surgical errors in the United States is now recorded at almost $1.5 billion annually. This astounding total comes from estimated figures released in July by the US Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ). It represents the additional costs for medical services that are passed along to employers and their healthcare providers.

Two categories of additional care required accounted for the major recipient of extra care dollars.

COSTS AT THE $1.5 BILLION MARK

Researchers found the insurers’ average payment for acute respiratory failure totaled $28,218, which added 52 percent more to medical costs. Next were post-operative infections, which required $19,480 additional dollars for a total of 48 percent higher costs.

Metabolic problems such as kidney failure or uncontrolled blood sugar contributed $11,797 in added dollars for a 32 percent increase.

The research work was conducted by the AHRQ’s William E. Encinosa and Fred J. Hellinger, both PhDs. Results of their study were published in the journal 

Also mentioned in this study was the fact that 1 out of every 10 patients who died within 90 days of their surgery did so because of preventable error. Of these, one-third occurred after discharge from the hospital. These figures came from a nationwide sample of 161,000 employer-insured patients age 18 to 64 that had surgery in 2001 and 2002.

Medicare has announced that as of October 2008, it will discontinue certain payments to hospitals for preventable medical error. It will be interesting to see how placing the financial burden on hospitals for post-error handling affects the number of surgical errors in this country.

Source: US Department of Health and Human Services, Agency for Healthcare Research and Quality. “New AHRQ Study Finds Surgical Errors Cost Nearly $1.5 Billion Annually.” July 2008. http://www.ahrq.gov/news/press/pr2008/surgerrpr.htm

Next came the additional care and handling associated with blood clots, vascular problems and pulmonary difficulties. This total came to $7,838 at 25 percent more. Open wounds associated with errors added $1,426 or 6 percent more.Health Services Research

When medical errors occurred, nursing costs rose as well by $12,196 for a 33 percent cost increase.

DOCTORS WHO ARE DEAD CONTINUE TO BILL

Dead doctors may have received upwards of $100 million in fraudulent Medicare payments for the first 7 years of this decade. If this type of criminal billing continues at its current rate, it could chew up as much as 15 to 20 percent of the entire Medicare budget for 2008.

Senator Norm Coleman (R MN), a ranking member of the Permanent Subcommittee on Investigations is conducting investigations into these fraudulent billing practices and recently presented his alarming findings at a Senate hearing entitled “Medicare Vulnerabilities: Payments for Claims Tied to Deceased Doctors.” The hearing was set to examine Medicare payments for durable medical equipment (DME) where claims had doctor identification numbers assigned to physicians who had been dead for at least one year prior to the date on the billing.

“In short, the subcommittee’s investigation uncovered some appalling facts,” Senator Coleman said. “The subcommittee found that between 2000 and 2007, Medicare paid for hundreds of thousands of DME claims in which the prescribing doctor had died years earlier. The estimated payments for those claims could be up to $100 million.” Here are some classic cases of abuse pointed out by the Senator:

MEDICARE FOR MILLIONS ANNUALLY

A Florida doctor died in 1999. Since then, his identification has been used by 3 different organizations to file fraudulent claims. The committee identified at least $350,000 in claims, with estimates of up to $500,000.

Another doctor passed away in 2001, and his ID number was used in over 3,800 claims totaling more than $354,000.

Still another doctor was listed in some 2,000 claims at over $478,000. Most alarming, according to the Senator, is that this issue of Medicare fraud was previously addressed with the Department of Health and Human Services in 2001. At that time, the paying agency – the Centers for Medicare and Medicaid Services (CMS) – agreed to work to fix the problem of paying dead doctors by April 2002. Apparently that has not occurred as 63 percent of the improper $100 million in payments were made after that date.

The subcommittee investigation shows that thousands of doctors who passed away in the 1990s are still active. Senator Coleman wants the system fixed and is calling on the CMS to get this done. He points out that the figure of $34 million made in improper payments in 2004 and 2005 would roughly total the size of the entire State of Minnesota general budget, all wasted on improper payments. As the Senator says, these are loopholes in the system that simply must be fixed and fixed now.

Source: Senator Norm Coleman of the Senate’s Permanent Subcommittee on Investigations. “Senator Coleman’s Opening Statement at PSI Medicaid Dead Doctors Hearing.” July 2009. http://coleman.senate.gov/public/index.cfm FuseAction=PressReleases.Detail&PressRelease_id=08fe1b37-d0a0-d47b-160c-bcdfebf373ef