Corporate influence on medicine, budgets & investors

July 14, 2002

Corporate Influence on Medicine, Healthcare Budgets, Investors

FYI

Because medicine’s pronouncements are so widely propagated and affect so many people’s lives, corporate influence and manipulation of the truth is more devastating than mere corporate accounting malfeasance. Recent revelations demonstrate how corporate influence and greed – rather than scientific evidence – has led to the proliferation of harmful, and often unnecessary treatments. Usually the drugs most lavishly promoted turn out to be no better than the snake oil treatments of yesteryear.

Washington Post columnist, Charles Krauthammer, MD noted: “Most shocking, perhaps, is the simple reminder of how contingent are the received truths of modern medicine…The problem is that even the most sophisticated scientific studies are limited by method, by modeling, by sampling and by an inevitable margin of error. Hence error and revision.” [Krauthammer, “When Modern Medicine Fails,” THE WASHINGTON POST, Friday, July 12, 2002]

The integrity of the scientific method in clinical trials and clinical practice has been corrupted: by biased sampling of subjects; by unequal comparisons between treatments; by suppression of negative findings, including deaths; by multiple published reports describing the same trial – which mislead the medical community into believing that the findings have been replicated numerous times; and by biased reports written by scientists under contract by drug comapnies.

Today, deceptive marketing campaigns reach millions of consumers and doctors because the FDA fails to intervene – as is its mandate. Consider how the evidence – which was known to the FDA for years – contradicts the claims made about the value of antidepressant drugs [See, The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration” by Irving Kirsch, Thomas J. Moore, et al, published by Prevention and Treatment, July 15, 2002: http://journals.apa.org/prevention/volume5/toc-jul15-02.htm

False marketing claims are an effective, though unethical method of increasing demand and inflating profits – even for drugs that are no better than sugar pills. False marketing claims have resulted in widespread overprescribing of psychiatric drugs – and they are bankrupting public healthcare budgets. In Massachusetts, for example, psychiatric drugs eat up half of the state’s $890 million drug budget. The Boston Globe reports (below) that on August 1 State Medicaid officials who are trying to contain Medicaid costs, will “warn doctors about a practice officials say costs millions and may harm some patients: physicians prescribing multiple psychiatric drugs – sometimes as many as seven – to individual patients.”

“Dr. Ken Duckworth, deputy commissioner at the state Department of Mental Health, said little scientific evidence exists that multiple drug regimens help patients, and that, in some cases, they may worsen side effects such as weight gain, agitation, and diabetes.”

This medically unsound practice of prescribing “drug cocktails” for psychiatric disorders – contradicts medical practice guidelines and demonstrates the absence of any scientific method for selecting one or another psychiatric drug. Clearly, the practice belies the widespread claims: these drugs are not effective treatments for the condition for which they are prescribed. Dr. David Osser, past president of the Massachusetts Psychiatric Society acknowledges: “This is improvisational fly-by-the-seat-of-the-pants medicine. The real question is why are all these people on all these medications?”

Other deceptive practices by the drug industry that inflate drug prices include, squelching competition from generic drug manufacturers. Several lawsuits are challenging such practices:

In December 2001, 29 states sued Bristol-Myers Squibb Co., alleging the company made false statements to federal regulators to extend its patent on the anti-anxiety drug, Buspar.

[See, States Go to Court in Bid to Rein in Price of Medicine, WSJ, May 21, 2002 http://www.bamcoalition.org/News/HW/05.21.01.htm

In Feb 2002, Nevada and Montana filed lawsuits against 17 drug companies, charging that the companies employed “deceptive practices” that constituted consumer fraud that hurt all residents of the states. Moreover, the Nevada suit says the drug makers, through a pattern of behavior, operated a racketeering “enterprise.”

Most recently, The Financial Times (followed by The New York Times) reported that Bristol-Myers Squibb is under investigation by the SEC, accused of “channel stuffing” – which (my husband, Itzhak Sharav, an accounting professor tells me) is cheating by overstating income before they have actually earned it – thereby misleading their investors. [MELODY PETERSEN, “Bristol-Myers Under Inquiry on Incentives for Drug Sales,” THE NEW YORK TIMES, July 12, 2002 http://www.nytimes.com/2002/07/12/business/12DRUG.html

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THE BOSTON GLOBE

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Massachusetts to Warn Doctors against Prescribing Multiple Psychiatric

Dugs By Liz Kowalczyk July 12, 2002

Massachusetts, grappling with soaring Medicaid prescription drug costs,

The Boston Globe – July 12, 2002

Massachusetts, grappling with soaring Medicaid prescription drug costs, will warn doctors about a practice officials say costs millions and may harm some patients: physicians prescribing multiple psychiatric drugs – sometimes as many as seven – to individual patients.

Medicaid officials, who are seeking new ways to control drug spending, recently turned their attention to psychiatric medications, which gobble up half the state’s $890 million drug budget. They said they were surprised by what they discovered: Nearly 5,000 patients on two or more antidepressants. More than 1,100 on five, six or seven different psychiatric medications. And even one mentally ill man for whom doctors simultaneously prescribed 15 mood stabilizers, antipsychotics, and anti-anxiety drugs.

Dr. Annette Hanson, the state’s Medicaid medical director, said that sometimes psychiatric patients are so ill with numerous overlapping problems that their treatment requires some sort of drug cocktail, just as for AIDS patients. But she said that for various reasons, including the movement toward shorter hospital stays, “poly-prescribing” or “poly-pharmacy” has gotten out of hand.

Dr. Ken Duckworth, deputy commissioner at the state Department of Mental Health, said little scientific evidence exists that multiple drug regimens help patients, and that, in some cases, they may worsen side effects such as weight gain, agitation, and diabetes.

On Aug. 1, the agencies will warn hundreds of doctors to cut back on unnecessarily prescribing medications for the state’s Medicaid psychiatric patients. If doctors don’t voluntarily restrict the practice, Hanson said, the state will consider requiring prior approval for psychiatric drugs – a measure patients’ groups strongly oppose.

The Medicaid program is tracking the prescribing habits of psychiatrists and physicians who treat the mentally ill and will send out two pharmacists to educate the most frequent poly-prescribing offenders. This approach, known as “counter-detailing,” is intended to give physicians more objective information than drug company sales people do during “detailing” visits, Hanson said.

“We are very concerned about this,” she said. Medicaid spent $45 million last year on the schizophrenia drug Zyprexa alone – the most money spent on any drug for Medicaid recipients. Officials don’t know how much money they will save by reducing multiple prescriptions for individuals but say the figure may be at least $20 million.

Medicaid is wading into a mysterious but well-established practice in psychiatric medicine. Many psychiatrists see poly-prescribing as part of the art of treating the mentally ill, a sort of improvisational medicine; they know that many expensive new psychiatric drugs – or combinations of them – work for some patients, but they don’t know exactly how. And they often can’t predict which drugs will help which patients.

“Sometimes psychiatrists are like mad scientists, and for some reason these wild combinations work,” said Toby Fisher, executive director of the Massachusetts Alliance for the Mentally Ill. “We can’t always say why, but we know the person hasn’t been in the hospital for a long time.”

In academic medical centers in particular, physicians increasingly believe that even similar drugs in the same class – the schizophrenia drugs Clozaril and Risperdal, for example – work on different neurotransmitters in the brain and may be more effective when combined. That’s given doctors license to overlap different medications, a practice growing more common, said Dr. Donald Goff, head of the schizophrenia program at Massachusetts General Hospital.

Medicaid, the state health insurance program for 900,000 needy residents, tends to cover the state’s most mentally ill residents; people with severe depression, anxiety, and schizophrenia often lose their jobs and their private health insurance.

“With a lot of patients, doctors have tried these drug combinations out of desperation because patients are so ill,” Goff said. “Everyone is trying to figure out the best way to proceed. Most studies say these medications end up saving money over the long haul by reducing hospital stays. Everyone looks at escalating pharmacy costs but not always at the big picture.”

Dr. Juan Avila, a psychiatrist at the South End Community Health Center, said one problem is that clinical trials on psychiatric medications are unrealistic. They often study “a very clean population” of patients on a single drug for one specific problem like severe anxiety.

But in “reality we deal with individuals with multiple problems and diagnoses, and we have to cope with all of these variables,” he said.

For example, Avila treats a woman who was admitted to the hospital twice for psychosis but who wants to take only herbal remedies. He persuaded her after several months to take low doses of two antipsychotics – Risperdal and Zyprexa – but she won’t take a higher dose of one.

“Someone may look at her prescriptions and say, ‘Why is he giving her two drugs and why low doses? This psychiatrist doesn’t know what he’s doing.’ But you have to look at the individual patient,” Avila said.

Goff said Mass. General and other medical centers now are more aggressively evaluating drug combinations. About one-third of schizophrenic patients are on more than one antipsychotic medication, he said, and he believes half are benefiting and half are not.

Many psychiatrists agree that poly-prescribing has gotten too common. Since managed care took off during the 1990s, insurance companies have enforced shorter hospital stays for psychiatric patients. This is true of patients with all types of health insurance, not just Medicaid. When stays were longer, doctors had time to “wash” old drugs out of patients’ bodies while they were still in the hospital before trying new medications. Now, with most patients in the hospital a week or less, doctors don’t have time to wean patients off old drugs first. And when patients are discharged on new medications, their regular physicians don’t want to upset the delicate balance by taking them off of their old drugs.

“In order to get patients out of the hospital, they snow them with medication so they aren’t doing whatever they were doing to get into the hospital,” Hanson said. “And then when they get out and go back to see their regular psychiatrist, he says, ‘Dr. So-and-So, a world-famous physician, put him on this. So who I am to take him off?’ The communication between inpatient and outpatient isn’t great.”

Psychiatrists often use medications to control symptoms – not treat causes of illnesses. And the number of drugs for various symptoms from insomnia to anxiety to hallucinations have exploded in the last decade, said Dr. David Osser, past president of the Massachusetts Psychiatric Society and a psychiatrist at the Brockton and Taunton Veterans Administration hospitals.

“If a patient can’t sleep, the path of least resistance is to add a sleep medication – even if they’re on four other drugs,” said Osser, who advised Medicaid on its plan to curb multiple prescribing. “This is improvisational fly-by-the-seat-of-the-pants medicine. The real question is why are all these people on all these medications?”

Osser recently treated a man with post-traumatic stress disorder who was taking five medications – an antidepressant, a mood stabilizer, two anti-epileptics, and an antipsychotic. He came in asking for a sixth drug, a tranquilizer. Instead, Osser said he signed up the man for cognitive therapy and eventually weaned him off all his medications.

Medicaid will phase in a program beginning Aug. 1 to limit the state’s drug list to the most effective and lowest-priced drugs for certain diseases. But for Medicaid programs across the country, controlling the cost of psychiatric drugs has been extremely difficult because patients’ groups have fought prior approval and other limits. Hanson said she understands patients’ concerns, which is why the program is trying an educational approach first.

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To see more of The Boston Globe, or to subscribe to the newspaper, go to http://www.boston.com/globe

(c) 2002, The Boston Globe. Distributed by Knight Ridder/Tribune Business News.

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