The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Investigations of Anemia Drug Profiteering Far from Over – Part II

Evelyn Pringle August 7, 2007

According to US Renal Data System and the Medicare Payment Advisory Commission, Medicare spends about $64,000 annually for each person on hemodialysis for all medical services, and the anemia drugs Procrit, Epogen and Aranesp are the single largest drug expense for Medicare.

In 2005, Medicare spent $2 billion on the drugs, and from 1991 to 2004, the cost of the medications to Medicare increased 716% from $245 million to $2 billion, according to a report by the US House Ways and Means Committee.

Amgen produced the synthetic epoetin in 1989 and sold it under the brand name Epogen as a treatment for anemic kidney patients and HIV related anemia. Shortly after Epogen came on the market, Amgen entered into an agreement to allow J&J to sell the same drug under the brand name Procrit, as long as it stayed out of the dialysis market, which basically helped the young company raise capital.

In 1993, J&J received approval to sell Procrit as a treatment for cancer patients with chemotherapy-related anemia, and a few years later, Amgen gained FDA approval for the long-lasting version of the drug, Aranesp, to treat both renal and chemotherapy related anemia.

Recent investigations have shown the drug makers are providing incentives to encourage the over-prescribing of ESA’s to Medicare patients by charging less for the drugs than the Medicare reimbursement rates.

A March 2006 government report entitled “Medicare Reimbursement for New End Stage Renal Disease Drugs,” found freestanding dialysis facilities on average were able to acquire Aranesp for between 14 and 27% below the Medicare reimbursement amounts in 2005.

On May 10, 2007, due to reports of rampant over-prescribing of the drugs for uses and doses not approved by the FDA and the deaths and injuries to patients as a result, the Oncology Drug Advisory Panel (ODAC) voted 15-2 in favor of adding new restrictions on the use of the drugs and voted 17-0 in favor of requiring the drug makers to conduct new clinical trials.

However, experts say the recommendations come about ten years and probably tens of thousands of deaths and injuries too late, because the FDA was made aware of the serious health risks associated with ESA’s in a report on the Amgen sponsored Normal Hematocrit Study back in 1996, and the FDA did little more than revise the product labeling a wee bit.

The 1996 study was designed to evaluate whether patients with chronic renal failure undergoing dialysis had fewer cardiovascular complications if the ESA was administered to attain a higher hematocrit level as compared to a lower level. The trial was terminated early because of a finding of more deaths and non-fatal myocardial infarctions in the patients randomized to the higher hematocrit target level.

The labeling revision recommended that the ESA’s not be used to achieve hematocrit in excess of 36%, or a hemoglobin level of 12 g/dL and was accompanied by the sponsor’s agreement to conduct a study to further examine the risk for blood clots among patients receiving ESA’s because an increased thrombotic risk was suspected to be one of the causes for the risks detected in the study, according to the FDA.

So ten years later, two clinical trials and an editorial finally appeared in the New England Journal of Medicine in November 2006, to report the risks associated with the use of ESA’s in the treatment of anemia from chronic renal failure.

The Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study showed increases in serious and potentially life-threatening cardiovascular events when Procrit was administered to reach higher hemoglobin levels, and the Cardiovascular Risk Reduction by Early Treatment with Epoetin Beta (CREATE) study trended toward more cardiovascular events in a pattern similar to the CHOIR study, thus strengthening the findings of the CHOIR study, the FDA said.

On June 26, 2007, Dr John Jenkins, Director of the FDA’s Office of New Drugs Center for Drug Evaluation and Research, testified at a hearing before the House Ways and Means Committee and said the study findings “underscore the importance of the warnings previously described in the labeling for Procrit, Epogen, and Aranesp regarding cardiovascular risks that include thrombotic events and increased mortality in hemodialysis patients who participated in the Normal Hematocrit Study.”

He told the Committee that the new studies, combined with the findings from the Normal Hematocrit Study, showed that patients with anemia due to chronic renal failure, whether or not receiving dialysis, “were at increased risk for serious cardiovascular complications when ESA’s were administered to attain hemoglobin levels in excess of the 12 g/dL level recommended in the ESA product labels.”

Dr Jenkins also said the FDA became aware of safety concerns about the use of ESA’s in cancer patients receiving chemotherapy between 2001 and 2003, when the agency received reports from two trials (BEST and ENHANCE) that demonstrated higher mortality and more rapid tumor growth when the ESA’s were given to maintain hemoglobin levels of greater than 12 g/dL and the findings were discussed at a May 2004 meeting of the ODAC.

He said the new safety data was added to the labeling for ESA products shortly after that meeting and that the advisory panel recommended additional data be gathered to further evaluate the new safety concerns about patients with cancer.

However, according to Dr Jenkins, it was not until late 2006 and early 2007 that the FDA was informed of several new trials in cancer patients that raised additional safety concerns.

In December 2006, the ESA makers informed the FDA of the interim results of the Danish Head and Neck Cancer Study Group trial (DAHANCA 10), a trial that compared radiation therapy alone to radiation therapy plus Aranesp in the treatment of advanced head and neck cancer.

The trial assessed whether treating anemia to achieve and maintain a hemoglobin concentration of 14.0-15.5 g/dL during radiotherapy would improve local-regional disease control.

The data monitoring committee for this trial found that 3-year local-regional control in patients treated with Aranesp was worse than for those not receiving Aranesp. Overall survival time also favored those not treated with Aranesp, he said, and the monitoring committee recommended the ESA treatment be stopped in the experimental arm on December 1, 2006.

Dr Jenkins said the FDA was notified in January 2007 of the results of a 989 patient trial of Aranesp in cancer patients with anemia who were not receiving chemotherapy when the target hemoglobin in the Aranesp treatment group was 12 g/dL.

The FDA’s analysis of the study data, he told the Committee, demonstrated that Aranesp did not significantly reduce the need for red blood cell transfusions and showed an increase in mortality in patients receiving Aranesp compared to those receiving placebo.

He said the FDA was also notified in February 2007 of the final results of a double-blind, placebo-controlled study that was designed to evaluate whether Epoetin alpha improved the quality of life for patients with non-small cell lung cancer who were not receiving chemotherapy with the dose titrated to maintain a hemoglobin level of 12 to 14 g/dL.

However, according to Dr Jenkins, this study was closed down in December 2003 after enrolling only 70 patients because its data monitoring committee found higher mortality rates in patients treated with Epoetin alfa.

Dr Jenkins informed the panel that the median time to death in patients treated with Epoetin alfa was 68 days and significantly shorter than the median time of 131 days in those treated with placebo. Also, he noted, treatment with Epoetin alfa did not significantly reduce the need for red blood cell transfusion or improve quality of life.

Dr Jenkins also explained that in 1996, the FDA approved the indication for use of ESA’s to reduce the need for blood transfusions in patients with hemoglobin values between 10 and 13 g/dL scheduled to undergo non-vascular, non-cardiac surgery.

Here, too, the approval was accompanied by a commitment to complete a post-marketing study to evaluate the risk for thrombotic events among patients who were not receiving preventive therapy with anti-thrombotic drugs.

In this case, according to Dr Jenkins, the FDA only received the results of this post-marketing study in 2007. Specifically, he said, the FDA was notified in February 2007 of the preliminary results of a trial with Procrit compared to the standard of care in patients undergoing spinal surgery.

“In this trial,” he said, “the frequency of deep venous thrombosis in patients treated with Procrit was 4.7 percent (16 patients), a rate more than twice that of patients who received usual blood conservation care (2.1 percent, seven patients).”

On June 26, 2007, Robert Vito, Regional Inspector General in Philadelphia at the US Department of Health and Human Services’ Office of Inspector General, testified at a hearing before the House Ways and Means Committee subcommittee and described cases where dialysis centers have been found to be overbilling Medicare for the anemia drugs.

He discussed a 2004 audit of payments to DaVita for ESA services provided at one Philadelphia dialysis center, which found that 44 of the 143 claims reviewed did not meet Medicare payment requirements.

In some cases, he said, they identified inconsistencies between the number of units prescribed in the physician order and the number billed to Medicare and also identified instances in which the drug was still administered to the patient after the doctor had ordered its discontinuation.

As another example, he told the committee that, in 2005, Gambro Healthcare, owner and operator of over 500 dialysis centers, agreed to pay over $350 million to resolve civil and criminal fraud allegations in the Medicare, Medicaid and TRICARE programs. To resolve its civil liability, he noted, Gambro paid $310.5 million for submitting false claims to Medicare and paying doctors improper remuneration related to their medical director services.

The new CMS reimbursement rules stipulate that cancer patients receiving chemotherapy should only use ESA’s if their hemoglobin levels fall below 10 and also limit the duration of therapy to a maximum of eight weeks after the completion of chemotherapy. They also limit the starting dose to match the FDA recommendations and limit the levels by which doses can be raised and Medicare will not cover treatment for anemic cancer patients who are not receiving chemotherapy or radiation.

The subpoena from New York Attorney General is just the tip of the iceberg when it comes to Amgen’s legal woes. The company’s failure to disclose the results of a Danish study in head and neck cancer has resulted in an inquiry by the SEC and several shareholder lawsuits.

According to the SEC filing, a class-action lawsuit was filed on May 11, 2007, in California, alleging that Amgen and its executives “made false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities.”

On May 14, 2007, the company was also served with a shareholder demand on the board of directors to establish a “special litigation committee” to investigate potential breaches of fiduciary duties by current or former officers and directors of the company, according to the filing.

The shareholders allege that these individuals violated core fiduciary duties, causing Amgen to suffer damages, and seek to recover damages resulting from their breach of fiduciary duties, monies and benefits improperly granted to them, insider trading proceeds and all costs associated with the inquiry by the SEC.

Filed under: 2007, Amgen, anemia drugs, Aranesp, cancer, dialysis, Epogen, Fraud, http://schemas.google.com/blogger/2008/kind#post, Johnson and Johnson, MEDICARE, Procrit

Feds Investigate Profits From Off-Label Stent Procedures – Part II

Evelyn Pringle May 2007

In addition to the federal investigations into the off-label marketing of drug eluting stent by Boston Scientific and Johnson & Johnson, on May 10, 2007, Rep Maurice Hinchey (D-NY), who serves on the House Appropriations Subcommittee, announced the introduction of the FDA reform bill which addresses the issue of doctors using products for unapproved uses, which usually occurs without the patient’s knowledge or consent.

If a doctor does not inform a patient that the FDA has not approved the use of a device or procedure, medical experts say, the patient cannot give meaningful consent because the potential problems that can result from the off-label use must be explained so that the patient can weigh the risks and benefits to determine whether to consent to the treatment.

Medical professionals point out that if a doctor wants to use a treatment that is not FDA approved because of a true belief that a certain patient would benefit from a specific treatment more than from others that are FDA approved, the doctor would not hesitate to explain the reasoning to the patient.

The FDA Improvement Act reform bill introduced by Rep Hinchey would require doctors to inform patients when a product is used off-label and also provide more resources to the FDA to go after companies that promote off-label use of their products despite the fact that doing so is illegal.

In recent months, lawmakers have made it clear that investigation of the stenting for profit industry is a top priority and will include not only the device makers, but also the doctors and medical facilities performing the procedures.

Being Congress oversees the spending by public programs like Medicare and Medicaid, lawmakers would have to be blind not to notice the obscene rise in profits. According to the May 17, 2007 Wall Street Journal, “Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees.”

Stenting doctors are very well paid. The median salary for invasive cardiologists who perform the procedures is roughly half-a-million dollars a year, says Darshak Sanghavi, a pediatric cardiologist and assistant professor of pediatrics at the University of Massachusetts Medical School, in Slate Magazine on May 8, 2007.

However, doctors and medical facilities may now be reevaluating the benefits of continued off-label stenting since law enforcement officials released information this month from an investigation by the FBI and the US Department of Health and Human Services of a cardiologist at a facility in Maryland that found 25 unnecessary stents implanted in patients in 2006 alone, with the majority billed to Medicare.

The bare-metal stenting procedure was originally marketed as a cheaper alternative to heart bypass surgery, but since the arrival of the DES, that claim is bogus. On February 25, 2007, the New York Times quoted the American College of Cardiology in reporting that the average cost of the DES procedure has risen to about $30,000, or almost equal to the price of open heart surgery for patients with multiple blockages.

The DES were promoted as being safer than bare-metal stents, but on March 8, 2007, the New England Journal of Medicine published an analysis of 4 studies that compared the DES and bare-metal stents with 4 years of follow-up, and found no significant differences in the rates of death, myocardial infarction, or stent thrombosis with the survival rate in the DES group at 93.3%, and 94.6% in the bare-metal group.

In December 2006, the FDA’s Circulatory System Devices Advisory Committee held a hearing to review data on the outcome of DES stenting when they were implanted according to their label compared to when they were used off-label. Dr Ron Waksman, of the Washington Hospital Center, told the panel the rate of stent thrombosis almost doubled in patients with off-label use versus on-label use at 30 days and at 12 months.

He also said, “when we look at on-label and at off-label, the drug‑eluting stents are more thrombogenic than bare-metal stents.”

With both on-label and off-label use, he informed the panel, over time, “late stent thrombosis is seen more in the DES versus the bare-metal stents.”

Dr Waksman said that careful patient selection for DES is mandatory, and “off-label use should be reconsidered or restricted.”

Diabetic patients with multi vessel disease should always be referred for bypass surgery, he added. DES should be contraindicated, he said, “for patients with poor compliance or allergic to Plavix or aspirin and need for upcoming surgery, and warning labeling should be considered for those when used off-label.”

But experts point out that some studies have shown little benefit from taking the anti-clotting, blood-thinning drug Plavix to prevent stent-thrombosis. In October 2006, Dr Alaide Chieffo, made a presentation at a Transcatheter Cardiovascular Therapeutics meeting and reported a study of 3,021 DES patients that found 9 out of 16 patients who had developed late stent-thrombosis were being treated with Plavix at the time.

At the FDA meeting, Dr Peter Smith of Duke University discounted the claims that stenting is safer or as effective as bypass surgery and warned of the importance of weighing the risks and benefits to patients treated with the different procedures.

He stressed that since the introduction of DES, too many patients in need of bypass surgery are instead receiving off-label stenting procedures. “A current perspective,” he said, “is that America’s number one killer is predominantly treated with percutaneous methodology that has not been demonstrated to provide a survival advantage.”

“And this is particularly important,” he advised, “for the treatment of multi vessel coronary disease where substantial quality of life and survival benefits have been conclusively demonstrated for bypass grafting.”

Dr Smith informed the panel of some of the outcomes reported in peer-reviewed published trials, the first a study of 14,000 patients, which demonstrated a significant survival advantage for bypass grafting compared to stenting in three vessel heart disease, he said.

The ROBUST New York State audited database, he reported, of 23,000 patients with three vessel disease published in the New England Journal of Medicine also showed a significant survival advantage for bypass grafting compared to stenting at 3 years.

Dr Smith explained that bypass grafting is more effective because it provides complete revascularization. While stenting treats the isolated blockage, grafting bypasses about two-thirds of the vessel where current and future blockage can occur.

In addition, he noted, bypass risks increase little with increasing coronary disease severity while risks with stenting appear to increase with each additional stent.

He also told the panel, “surprisingly, when we looked at the bare-metal stent era data, we saw point estimate trends favoring bypass grafting even for low and intermediate severity disease, and an extension of the significant advantage that bypass grafting provides compared to intervention for high severity coronary disease.”

Dr Smith said the introduction of the DES led to a tripling of the use of stenting for high severity coronary disease. “And for the first time,” he noted, “less than half the patients were initially offered coronary bypass grafting.”

“How can this happen,” he pointed out, “with the absolute survival advantage that I’ve shown you from these observational data on 40,000 patients showing that at 1 year, there’s a 2.3 percent advantage, absolute advantage in bypass grafting versus stenting; 4.3 percent at 3 years; 5.1 percent at 5 years.”

That means 1 out of every 20 patients, he said, who were treated with stenting would have survived if they had had bypass grafting. When you translate into real world application, assuming that drug‑eluting stents are equivalent to bare-metal stents for the mortality outcome, he advised, approximately 1.5 million drug‑eluting stents are implanted worldwide, 850,000 in the US.

Using data from the DEScover trial about stents per patient in the incidence of three vessel disease, he said, we estimate that 160,000 are with DES worldwide and 92,000 in the US.

Dr Smith informed the panel that this translates into a rate of premature death at 1 year to 3,800 patients worldwide, with 2,000 in the US, and 16,000 patients deaths at 3 years, with 9,000 in the US.

“Annualized,” he said, “this is 6,500 worldwide, 3,600 in the U.S.”

At the end of his presentation Dr Smith addressed previous claims made to the panel by the industry that off-label extension of DES was meeting “an unserved need.”

“We’re not certain whose unserved need that is,” he said, “but we’re fairly certain that it’s not the need of our patients.”

Another major selling point used by the stent makers has been to claim that bypass surgery is riskier. However, a study presented at the American Heart Association’s Annual Conference in April 2007, determined that the DES procedure and surgery have about the same risk for a major cardiac event based on an analysis of 799 DES patients and 799 bypass patients for outcomes in the first 30 days and during the following 3 years.

Lead author, Dr Wilson, a program director at St. Luke’s Episcopal Hospital and Texas Heart Institute, said in Science Daily on April 21, 2007, “We found that the likelihood of any complication in the hospital was the same whether you had a drug-eluting stent or bypass.”

“Five percent of drug-eluting stent patients,” he said, “had some major complication in the hospital, mostly heart attack, as opposed to about 3.8 percent of the patients who had bypass.” At 3 years, the study found, the death rate with bypass was 6.6% and 9% with drug-eluting stents.

The results of a study called COURAGE released in March 2007, may turn out to be the final nail in the coffin for Boston and J&J. The study involved over 2,000 patients who were treated for chronic, stable chest pain, and revealed that medication therapy alone reduced chest pain almost as well as when the drugs were combined with stenting.

Experts say the outcome is probably due to the fact that stenting only fixes one artery blockage at a time while drug treatment affects all arteries.

Many stable heart patients are conned into stenting because they believe that it will extend their lives and lower their risks for heart attack but according to the New York Times, the COURAGE study found that patients who received stents and drugs had the same life expectancy and same number of heart attacks as patients who received drugs only.

The study reported the rate of heart attack, stroke or death in patients who received stents was 20%, compared to 19.5% in patients who used drugs alone. At the end of 4.6 years, there were 211 deaths, or 19% among patients in the group who received stenting compared with to only 202 deaths, or 18.5% in the medication group.

“Our findings parallel those reported in recent trials,” said William Boden, chief of cardiology at Buffalo General and Millard Fillmore Hospitals.

“In the aggregate,” he told United Press International on March 26, 2007, “these studies … show that percutaneous coronary intervention — angioplasty plus stenting — has no effect in reducing major cardiovascular events.”

“There are hundreds of thousands of Americans who are currently getting stents placed who do not need it as initial therapy,” said Dr Raymond Gibbons, professor of medicine at the Mayo Medical School and president of the American Heart Association, to UPI.

In response to the study, on the March 28, 2007, WSJ Health Blog, Dr Andy Demajio wrote, “It has been distressing to see how interventional cardiologists have been happily stenting their patients to fatten their wallets.”

“This immoral practice should come to a stop,” he wrote. “My hope is that the COURAGE data may help payers take action against these doctors.”

It appears that doctors and hospital administrators are thinking twice about off-label DES stenting. On May 17, the Wall Street Journal reported that April marked the 10th consecutive month of share decline for DES, quoting the Millennium Research Group, a firm that surveys about 140 US hospitals, that put the percentage of stentings with a coated stent at 69.7%, down from almost 90% last in June 2006.

Until April doctors had largely replaced the more-expensive DES with older, bare-metal stents, the Journal said. “The new data,” it notes, “indicate that doctors and patients may be skipping stentings completely in favor of drug treatment.”

It sure looks that way according to Boston’s first quarter SEC filing, that reported worldwide sales of its DES had dropped to $468 million in the first quarter of 2007, down from $633 million during the first quarter of 2006.

The SEC filing also shows that J&J has plenty of other problems. For instance, the company is currently facing over 75 class action lawsuits and 1,100 individual lawsuits related to potentially defective defibrillators and pacemakers manufactured by Guidant, a company Boston acquired in April 2006.

J&J future isn’t looking too rosy either. Sales of the Cypher stent are down by more than 25%, according to the firm’s first quarter SEC filing and in addition to DES, J&J is currently under federal investigation over the marketing practices for several other products including the antipsychotic Risperdal, the anti-seizure medication Topamax, the heart-failure drug Natrecor, and paying kickbacks to doctors for using the firm’s orthopedic devices.

In March 2007, J&J received new subpoenas from US attorneys in Philadelphia, Boston and San Francisco pertaining to the investigations of the 3 drugs seeking information about corporate supervision and oversight of the subsidiaries that market the drugs including Janssen, Ortho-McNeil and Scios.

In addition, according to SEC filings, as of December 31, 2006, 100 lawsuits were pending against J&J related to the Charite artificial spinal disc, basically alleging that the company knew the disc was defective and boosted profits by marketing the device for off-label uses.

On May 10, 2007, the Wall Street Journal reported the filing of a lawsuit against J&J by two former salesmen with documents showing how the company “sought to boost sales of its blockbuster anti-anemia drug Procrit by offering contracts that fattened doctors’ profits and urging its salespeople to push higher-than-approved doses.”

This bit of news came shortly after federal lawmakers ordered J&J to cease all direct-to-consumer advertising and physician incentives for Procrit until the FDA could determine whether steps needed to be taken to protect the public following investigations that revealed the rampant off-label sale of the anemia drug was causing serious injuries and death among kidney and cancer patients.

Unfortunately, there is no way to medically reverse the stenting procedure and therefore, the millions of unsuspecting patients who received the DES face a life-time of every day worry because a blot clot lodged in a stent can cause a stroke or heart attack without any warning.

Legal experts are predicting that Boston and J&J will be swamped with lawsuits over the off-label marketing of DES, but say the defendants listed in the complaints will likely include the names of doctors and medical facilities that helped the device makers turn the stenting industry into a billion dollar baby.

Filed under: 2007, anemia drugs, Boston Scientific, Charite, http://schemas.google.com/blogger/2008/kind#post, Johnson and Johnson, medical devices, MEDICARE, Medtronic, Plavix, Procrit, stents

Tracking the American Epidemic of Mental Illness – Part III

Evelyn Pringle June 9, 2010

The Psychopharmaceutical Industrial Complex

For the past two decades, the Psychopharmaceutical Industrial Complex has been the driving force behind the epidemic of mental illness in the United States with the promotion of biological psychiatry and a bogus “chemical imbalance” in the brain theory.

The Psychopharmaceutical Industrial Complex (PPIC) is a symbiotic system composed of the American Psychiatric Association, the pharmaceutical industry, public relations and advertising firms, patient support organizations, the National Institute of Mental Health, managed care organizations, and the flow of resources and money among these groups, according to an October 1, 2009 paper in the Journal of Mental Health Counseling, by Dr Thomas Murray, director of Counseling and Disability Services at the University of North Caroline School of Art.

Murray’s paper draws parallels between cult indoctrination and PPIC techniques and notes the similarities between cult members and mental health consumers who are vulnerable to losing their identities to the PPIC.

The PPIC and “its adherence to the disease model pervades mainstream culture and greatly impacts psychotherapy,” he says. “Consequently, the effects of the PPIC may have resulted in some psychiatric consumers adopting disease-model messages in ways similar to cult indoctrination.”

“Consumer adoption of the disease model can create obstacles to treatment when hope is fundamental,” he advises.

Murray says his most difficult cases “involve clients who have in essence been drawn into the PPIC and have become resigned to the disease model with little sense of empowerment to overcome their emotional problems.”

“These are the consumers who have little self-efficacy and little hope that they have options other than to suffer,” he reports.

“Insurance companies rely on pharmaceuticals to contain costs (and limit psychotherapy sessions), and reimbursement depends on a diagnosis of a diseased brain,” Murray notes.

For psychiatrists, insurance “companies typically encourage short medication visits by paying nearly as much for a 20-minute medication visit as for 50 minutes of therapy,” according to the April 19, 2010, New York Times article, “Mind Over Meds,” by Dr Daniel Carlat, author of the Carlat Psychiatry Blog, and the new book, “Unhinged: the Trouble With Psychiatry.”

Psychiatrists have become enthralled with diagnosis and medication and have given up the essence of their profession – “understanding the mind,” Carlat reports in his book.

“We have become obsessed with psychopharmacology and its endless process of tinkering with medications, adjusting dosages, and piling on more medications to treat the side effects of the drugs we started with,” he says. “We have convinced ourselves that we have developed cures for mental illnesses … when in fact we know so little about the underlying neurobiology of their causes that our treatments are often a series of trials and errors.”

Back in December 2003, a study in Psychiatric Services on “financial disincentives” for psychotherapy noted that psychiatrists could earn about $263 an hour doing three 15-minute “medication management” sessions, verses about $156 for a 45 to 50-minute therapy session, representing a pay cut of close to 41% per hour for doing therapy only.

The most common excuse given for the high rate of prescribing psychiatric drugs is that talk, behavioral, cognitive or other forms of non-drug treatment cost too much. However, in 2008, more than $24 billion worth of antidepressants and antipsychotics were dispensed. “Such expenditure would employ 240,000 psychotherapists earning an annual income of $100,000 to provide 6 million hours of psychotherapy averaging 25 client-hours a week,” Murray estimates.

These figures do not include what would be possible using the additional revenue generated by the sales of antianxiety, hypnotic, and psychostimulant drugs, he says.

Drug Makers Pay Prescribing Shrinks Top Dollar

Vermont is one of the few states that requires pharmaceutical companies to disclose the money spent on marketing drugs to prescribers each year. In 2009, the report by the state’s Attorney General, showed that during the period July 1, 2007, through June 30, 2008, pharmaceutical companies spent approximately $2.9 million, in a state with a population of less than 609,000, on consulting and speaker fees, travel expenses, gifts, and other payments to or for physicians, hospitals, universities and others authorized to prescribe or dispense pharmaceutical products.

“The greatest amount of expenditures went to psychiatrists as a group, totaling nearly half a million dollars; one psychiatrist received over $112,000, the greatest amount of pharmaceutical marketing dollars spent on any single person,” the report states.

Eleven psychiatrists made the top 100 recipients list with an average payment total of $43,473. Shrinks also received the highest pay in 2007, when 11 earned a total of $626,379, or about 20% of the total payments made that year.

The top five spenders in last year’s report were Eli Lilly, Pfizer, Novartis, Merck and Forest Pharmaceuticals, with $242,730 listed for the promotion of depression medications and $217,983 for ADHD drugs.

Lilly was the top spender in Vermont for 3 years in a row. The company’s psychiatric drug portfolio includes Zyprexa, Prozac, Cymbalta, Strattera, and Symbyax, a combination of Prozac and Zyprexa. A list of drugs in the report shows the most marketing dollars went for Lilly’s ADHD drug Strattera and spending on its antidepressant Cymbalta was second. Forest’s Lexapro ranked fifth and Pfizer’s atypical antipsychotic Geodon was in the thirteenth position.

The drug makers now even have general practitioners wildly writing prescriptions for psych drugs. A study in the September 2009 journal, Psychiatric Services, reported that 59% of prescriptions for mental health drugs in the US are written by family doctors, not psychiatrists.

Drug Peddling in the Military

In a joint project with Northwestern University’s Medill School of Journalism, the Center for Public Integrity reviewed travel disclosure forms filed by Department of Defense personnel from 1998 through 2007, and found the medical industry was the largest sponsor of free travel, accounting for about 40% of all trips.

According to their June 2009 report, “Pentagon Travel,” there were 8,700 trips by DOD personnel paid for by the healthcare industry, at a price tag of more than $10 million, with sponsors that included drug and device makers as well as health foundations and trade groups often funded by those companies.

“Drug companies and device manufacturers spent about $1.7 million for more than 1,400 trips taken by DOD doctors, medical researchers, pharmacists, and other health care employees over the decade, creating relationships that pose serious conflict of interest issues, according to medical ethics experts,” the Center said in a study summary titled, “Medical Industry Showers DOD with Free Travel.”

“Of special interest to the industry were DOD employees who prescribe, purchase, or recommend the use of drugs or medical equipment,” the Center notes.

DOD’s pharmacy system employees, who can influence which drugs are selected at base pharmacies, took more than 400 trips, worth over $400,000, from medical industry sources, according to the Center’s analysis.

The review found drug companies paid more than $115,000 for trips to destinations that included Orlando, Las Vegas, San Diego, New York City, New Orleans, Paris, and Rome.

Shahram Ahari worked as a sales rep for Eli Lilly in 1999 and 2000, and described how he used free meals, trips, and unrestricted grants to subtly seduce civilian physicians into prescribing Lilly’s drugs. The strategy was to make friends with doctors and pharmacists to get them talking about the drugs and then reward them with additional perks for prescribing the drugs.

“The return on dividends is phenomenal,” Ahari says in the summary. “If it costs them a thousand dollars for a dinner, that’s a [patient’s drug] payment for one month.”

“If they fly you on the Concord to Paris for five grand, even if they get one patient out of it, it’s a lifetime of cash,” he pointed out.

From fiscal year 2000 to fiscal year 2006, the Pentagon’s prescription drug spending more than tripled from $1.6 billion to $6.2 billion, according to an April, 2008 Government Accountability Office report.

The head of the DOD’s pharmaceutical program, Rear Admiral Thomas McGinnis, banned his own staff from going on company-paid trips, but other military pharmacy staff took about 400 trips, the Center points out.

Drug spending hit $6.8 billion in 2008, said McGinnis, and “the GAO expects DOD pharmaceutical spending to reach $15 billion by 2015,” according to the summary.

In a May 19, 2009, report for MSNBC titled, “U.S. military: Heavily armed and medicated, Melody Petersen pointed out that military physicians “can be swayed by the aggressive promotional efforts of the pharmaceutical industry just like civilian doctors often are.”

Military rules limit the handouts doctors can take from drug companies, she says. “A doctor can go to a dinner paid for by a drug company, but the meal’s value can’t be more than $20, and the value of all gifts received from a company over the course of a year can’t exceed $50. “

However, drug companies find ways to work around the limits. For instance, Petersen reports that when “thousands of military and federal health-care professionals met in November (2008) for the annual meeting of the Association of Military Surgeons of the United States (AMSUS), more than 80 pharmaceutical companies and other health-care firms were on hand.”

“The companies helped pay for that San Antonio event in exchange for the opportunity to set up booths in the convention hall, where sales reps pressed doctors to prescribe their products or to use their medical equipment and devices,” she notes.

The 6-day meeting also included a celebration, she reports, “15 military and federal doctors and other health professionals received awards that included cash prizes provided by various drug companies.”

On March 17, 2010, Navy Times ran the headline, “Medicating the Military,” to report a Military Times investigation that found 1 in 6 service members is on some form of psychiatric drug.

“And many troops are taking more than one kind, mixing several pills in daily “cocktails” — for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches — despite minimal clinical research testing such combinations,” the Times noted.

The investigation also found that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.

“It’s really a large-scale experiment. We are experimenting with changing people’s cognition and behavior,” says Dr Grace Jackson, a former Navy psychiatrist and author of the book, “Drug-Induced Dementia: A Perfect Crime,” in the article.

Troops and military health care providers told Military Times that these drugs are also being prescribed, consumed, shared and traded in combat zones, despite some restrictions on the deployment of troops using those drugs.

The Times investigation of records obtained from the Defense Logistics Agency showed $1.1 billion was spent on common psychiatric and pain medications from 2001 to 2009, and the use of psychiatric drugs had increased 76% overall, since the start of the current wars.

Orders for antipsychotics rose by more than 200%, and annual spending more than quadrupled, from $4 million in 2001, to $16 million in 2009. Orders for anti-anxiety drugs and sedatives increased 170%, and spending rose from $6 million to about $17 million. Annual orders of anticonvulsants had a 70% increase, with spending more than doubled, from $16 million to $35 million.

Antidepressants orders had a 40% gain, but an overall decrease in spending, from $49 million in 2001 to $41 million in 2009, due to the arrival in recent years of cheaper generic versions of the drugs.

Collateral Damage

During the same time frame, from 2001 to 2009, the Army’s suicide rate increased more than 150%, from 9 per 100,000 soldiers to 23 per 100,000, and the Marine suicide rate increased about 50%, from 16.7 per 100,000 in 2001, to 24 per 100,000 marines in 2009.

In a June 20, 2009, commentary for Huffington Post titled, “Antidepressants Cause Suicide and Violence in Soldiers,” Dr Peter Breggin, author of “Medication Madness: The Role of Psychiatric Drugs in Violence, Suicide, and Murder,” dismisses the theory that the increased use of prescription of drugs in the military is a response to increased depression among the soldiers.

“In reality,” he says, “the use of psychiatric drugs escalates when, and only when, drug companies and their minions target new markets.”

“In this case, the armed services have been pushing drugs as a cheap alternative to taking genuine care of the young men and women in our military,” he states. “Instead of shortening tours of duty, instead of temporarily removing stressed-out soldiers from combat zones, and instead of providing counseling – the new army policy is to drug the troops.”

“During Vietnam, a mere 1% our troops were taking prescribed psychiatric drugs,” he reports. “By contrast, in the past year one-third of marines in combat zones were taking psychiatric drugs.”

In Medication Madness, Breggin evaluated more than fifty cases of suicide, violence, mania and crime induced by psychiatric medications, especially the new antidepressants.

Atypical antipsychotics produce a potentially disastrous “metabolic syndrome” that includes elevated blood sugar, elevated cholesterol, elevated blood pressure, and severe obesity, according to Breggin in a 2009 Psychiatric Drug Facts Newsletter.

“They can also cause direct harm to the function of the heart,” he says. “Overall, it’s a prescription for cardiac disease and premature death.”

As far as claiming the increase in suicides is due to increased horrors in the current wars, California neurologist, Dr Fred Baughman points out: “Who can claim that one war is any more horrible, evil or effecting than another?”

“What jumps out as different about these wars,” he says, “are veterans and soldiers saturated with psychiatric drugs, and kept on the front lines or sent back to the front lines time after time.”

“These frequent, sudden deaths occurring in the military are due to its policy of reckless, anti-scientific, psychiatric drugging,” he warns.

Veterans Dying

“Official figures regarding military “suicides” also have to be taken with a grain of salt,” Baughman says.

In 2008, after reading an article in the Charleston Gazette, titled “Vets Taking Post Traumatic Stress Disorder Drugs Die in Sleep,” Baughman began to investigate veterans dying in their sleep because the deaths did not make sense. “Young men in their twenties do not suddenly die for no reason,” he points out.

He specifically investigated the deaths of four West Virginia veterans who died unexpectedly in their sleep in 2008, including Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson. At the time, Stan White, Andrew’s father, knew of eight such cases in Kentucky, Ohio and West Virginia.

Baughman learned that all four veterans had been diagnosed with PTSD and all were taking the same three-drug cocktail consisting of Seroquel, an atypical antipsychotic, Paxil, an antidepressant, and the anti-anxiety drug, Klonopin.

His investigation determined they did not commit suicide or go into a coma, as a result of an accidental mixed drug overdose, as suggested by the military. “None of the veterans who died in their sleep were drunk, drugged, or overdosed when they went to bed, they all appeared normal,” Baughman says.

Within a year, he had learned of between 70 and 80 more similar cases. “These are undoubtedly sudden cardiac deaths,” he reports, “due to the prescription of antipsychotics and antidepressants.”

“Although antipsychotics and antidepressants have been proven to increase the risk of sudden cardiac death, they are routinely prescribed together, as if no such risk is known,” Baughman warns.

He points to the January 2009 study, Ray et al, which reported that antipsychotics double the risk of sudden cardiac death, and that on March 17, 2009, Whang et al reported antidepressants, as well, increase the rate of sudden cardiac deaths.

Sudden cardiac death has been defined as the “unexpected natural death” from a cardiac cause. Some studies suggest that 85 to 90% of these deaths result from ventricular tachyarrhythmias and medications may contribute to the risk of these underlying arrhythmias. Ray et al found atypical antipsychotics increased the risk for arrhythmias.

As of May 24, 2010, by conducting Google searches on the internet, veteran’s wife, Diane VandeBurgt, of Charleston, found 128 deaths of veterans using terms such as “dead in barracks,” “in bed,” “at work station.” Diane’s husband quit taking Seroquel, prescribed as sleep aid as part of his PTSD treatment, after experiencing many terrible side effects.

Andrew White joined the Marines because he wanted to follow in the footsteps of his older brothers. One brother served in the army and the other in the Navy.

Andrew returned from Iraq in September of 2005 and less than two weeks later his brother was killed in Afghanistan. “Andrew had not even emptied his bags when we all had to deal with this loss,” his mother Shirley recalls. Shirley and her husband, Stan, have been on a non-stop mission to find answers for Andrew’s death and the deaths of other veterans.

The soldiers, veterans, and their families deserve the truth about this epidemic of antipsychotic-antidepressant sudden cardiac deaths in the military, Baughman states.

“Most importantly,” he says, “they cannot be allowed to continue to cover up these deaths and dole out psychiatric drug cocktails as they are doing to the exclusion of psychotherapy.”

“The number of Americans on government disability due to mental illness skyrocketing from 1.25 million in 1987 to over 4 million today is an iatrogenic, physician induced epidemic that will only mount in the future,” Dr Baughman says. “The utter, complete fraud based on the fiction of psychiatric diseases has got to stop.”

Invented Diseases

Unlike a medical diagnose that indicates a probable cause, treatment and prognosis, mental disorders are voted into existence by committees representing the American Psychiatric Association, a roughly 38,000 member professional group, that gets to decide what is normal, and what is not, for the more than 300 million other people in the US.

The APA’s “Diagnostic and Statistical Manual for Mental Disorders IV (DSM IV),” contains all the billable mental disorders and amounts to nothing much more than a bunch of checklists of symptoms. The original 1952 version contained just over 100 disorders. By the fourth edition the number had more than tripled to over 350. The DSM5 is due for publication in May 2013.

The DSM is immensely important to drug makers because the FDA will not approve a medication to treat a disorder unless the condition is listed in the manual. For the DSM IV, fifty-six percent of of the 170 panel members, and one-hundred percent of the experts involved in writing diagnostic criteria for “mood disorders” and “schizophrenia and other psychotic disorders,” for which medication is standard treatment, had financial ties to the drug companies, according to a 2006 study titled, “Financial Ties Between DSM-IV Panel Members and Pharmaceutical Industry,” in the “Psychotherapy and Psychosomatics” journal.

The leading categories of financial interest for panel members were research funding (42%), consultancies (22%) and speakers bureau (16%).

The authors of the DSM5 have agreed to limit their industry income to $10,000 or less per year until the completion of their work. But as Dr J Wesley Boyd, an academic psyhiatrist, pointed out in an April 11, 2009 editorial in the Boston Globe:

“Even if these individuals adhere to the stated income limits, how much pharmaceutical funding is being funneled into the authors’ respective departments by way of lectureships, endowed chairs, or sponsored research? And if the authors are free to resume their usual heavier ties to industry after 2012, how can the promise of big payouts later not influence their current work?”

In 2003, a group of psychiatric survivors went on a hunger strike in California with the goal of forcing the APA and the National Alliance on Mental Illness to acknowledge that there was no scientific proof for the claim that mental illness was biological in nature. Three weeks into the strike, the APA issued a statement admitting that “brain science has not advanced to the point where scientists or clinicians can point to readily discernible pathologic lesions or genetic abnormalities that in and of themselves serve as reliable or predictive bio-markers of a given mental disorder or mental disorders as a group.”

The marketing strategy in psychiatry is to invent diagnoses out of thin air and call them diseases as a means to prescribe drugs, says Dr Baughman.

“They take entirely normal people and create patients by diagnosing them with fictional diseases,” Baughman says. “It’s a total fraud.”

To validate this point, he tells how he helped a father in Canada, whose son had been diagnosed with multiple disorders, write a letter to Health Canada, an agency similar to the FDA, asking for information on ways to validate a diagnosis of mental illness.

In a November 10, 2008 response letter, Health Canada stated: “For mental/psychiatric disorders in general, including depression, anxiety, schizophrenia and ADHD, there are no confirmatory gross, microscopic or chemical abnormalities that have been validated for objective physical diagnosis. Rather, diagnoses of possible mental conditions are described strictly in terms of patterns of symptoms that tend to cluster together.”

Baughman then wrote a similar inquiry to the FDA Commissioner, and forwarded a copy of Health Canada’s letter. Donald Dobbs, from the Center for Drug Evaluation and Research, consulted with the FDA’s new drug review division, and responded to Baughman’s inquiry by stating: “…they concurred with the response you enclosed from Health Canada. Psychiatric disorders are diagnosed based on a patient’s presentation of symptoms that the larger psychiatric community has come to accept as real and responsive to treatment. We have nothing more to add to Health Canada’s response.”

“The entirely bogus stigmatizing labels are a barcode on the forehead of a child, and once a label gets in a record, it sticks,” Baughman warns. “These children are going to have problems getting health insurance and trouble finding employment.”.

As a neurologist, “I would say that a third to a half of all the patients I saw had no organic disease,” he says. “Now contrast that with a 2002 survey of child psychiatrists, where 91% of the kids were given a drug.”

“It’s not just psychiatry, it’s pediatrics, neurologists, family practitioners, and psychologists all across the country,” he states. “They have all become members of the child drugging establishment.”

An alarming study by researchers from Thomson Reuters and the US Substance Abuse and Mental Health Services Administration reviewed 472 million prescriptions for psychiatric drugs from August 2006 and July 2007, and found general practitioners wrote more than half of prescriptions in two main classes of drugs, 62% of antidepressants and 52% of stimulants. Family doctors also wrote 37% of prescriptions for antipsychotics, and 22% of anti-mania drugs, the study showed.

The researchers were especially concerned over antipsychotics being prescribed by general practitioners. The fact that antipsychotics may be more complex to prescribe, have some potentially serious side-effects, “emphasizes the need to understand the adequacy of care being provided by a GP,” said Tami Mark, director of analytic strategies for the healthcare and science business of Thomson Reuters.

Attack on Child Drugging

The massive drugging of America’s children, particularly poor, disadvantaged children and youth through Medicaid and in foster care, is an unfolding public health catastrophe of massive proportions, according to Alaskan attorney, Jim Gottstein, the leader the Law Project for Psychiatric Rights. Gottstein and PsychRights have made attacking this problem a priority.

In letters to several federal lawmakers in May 2009, Gottstein reported the massive Medicaid Fraud involved in the prescribing of psychiatric drugs to children covered by Medicaid. Copies of the letters were also sent to Kathleen Sebelius, Secretary of Health & Human Services, Kerry Weems, Acting Administrator, CMS, and Joyce Branda, Director of the Department of Justice Commercial Litigation Branch (Frauds).

“The fraudulent activities of drug companies in promoting off-label pediatric use of psychiatric drugs … has begun to be exposed, but the psychiatric drugging of America’s children and youth goes on unabated,” Gottstein advises in the letters.

While preparing the filing of a lawsuit to prohibit the State of Alaska from paying for psychiatric drugs prescribed off-label to children covered by Medicaid in Alaska, Gottstein led an investigation that determined the vast majority of psychiatric drugs prescribed to kids on Medicaid constitute fraud. A tremendous percentage of the prescriptions did not qualify for reimbursement the letters point out:

“For example, no anti-convulsants masquerading as “mood stabilizers,” such as Depakote or Tegretol, have been approved for pediatric psychiatric use or supported by any of the compendia. However, these drugs, especially Depakote, are routinely paid for by Medicaid without any apparent consideration that the practice has been prohibited by Congress.

“With respect to the second generation neuroleptics, no pediatric use of Seroquel, Zyprexa or Geodon is approved by the FDA or supported by any of the designated compendia. Risperdal is approved for very narrow uses, as is Abilify, but even when prescribed for these indications, they are almost always prescribed concurrently with another drug(s), which is not FDA approved or supported by any of the designated compendia.”

In 2007, through a state FOI request, PsychRights found Alaska Medicaid was paying approximately $123,000 per month for anticonvulsants prescribed to kids and $288,000 for second generation neuroleptics for a “total averaging approximately $411,000 per month in improper Medicaid payments in Alaska alone.”

“Extrapolating this to the entire country,” the letters state, “there is over $2 Billion in Medicaid payments for psychiatric drugs to children and youth that Congress has explicitly prohibited.”

“In truth,” Gottstein says, “this is the smallest amount because typically two or more of these drugs are administered concurrently, in what is called polypharmacy, none of which has been approved by the FDA for pediatric use or supported by any of the designated compendia.”

“It is hard to come up with an adjective that adequately conveys the horror this is inflicting on America’s children and youth,” he states. “Suffice it to say that when the country wakes up to the carnage this has caused, it will be recognized as the largest iatrogenic (doctor caused) public health disaster in history.”

In January 2010, PsychRights announced the unsealing of a major Medicaid Fraud lawsuit against psychiatrists, their employers, pharmacies, state officials, and a medical education and publishing company for their roles in submitting fraudulent claims to Medicaid. The complaint was filed on April 27, 2009, under the federal False Claims Act which allows private parties to bring fraud actions on behalf of the Government, but was kept under seal until January 2010. The defendants include more than a dozen child psychiatrists, Alaska officials, health care agencies, and pharmacies.

PsychRights has also developed a streamlined model Qui Tam Complaint for use by interested attorneys around the country. The complaint is drafted for former foster children to bring the lawsuits and receive the whistleblower’s share of the recovery, but anyone with knowledge of specific offending prescriptions, such as parents and mental health workers, can bring suit.

Last fall, Gottstein gave presentations on how to file and conduct these types of cases at the national conventions of the National Association for Rights Protection and Advocacy (NARPA), and the Internation Center for the Study of Psychiatry and Psychology.

While PsychRights is not bringing these cases for the money, such lawsuits represent a tremendous financial opportunity for attorneys to do well by doing good. “These are about as open and shut as cases can get,” Gottstein says, “it is Medicaid fraud to cause or submit prescriptions to Medicaid for reimbursement if they are not for a medically accepted indication. End of story.”

(This series is sponsored by the International Center for the Study of Psychiatry and Psychology http://icspponline.org/index.html)

Filed under: 'ADHD', 2010, antipsychotics, APA, drugging children, DSM, front groups, http://schemas.google.com/blogger/2008/kind#post, ICSPP, military, SSRIs, veterans

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