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"Drug companies not only write checks to hospitals, they write checks to politicians...They write checks to both sides of the aisle."
Two separate news reports provide a glimpse into the intricate web of corruption that has engulfed public health policy under the covert influence of pharmaceutical companies whose political reach determines state and federal policy commitments for the purchase of drugs.
The New York Times reports: "An internal investigation by the Department of Health and Human Services confirms that the top Medicare official threatened to fire the program's chief actuary if he told Congress that drug benefits would probably cost much more than the White House acknowledged." But according to the Administration officials, concealing information from Congress is not a crime.
The Philadelphia Daily News and Associated Press report that Pennsylvania psychiatrist, Dr. Stefan P. Kruszewski, filed a federal whistleblower lawsuit charging major pharmaceutical companies, state officials, and state contractors with public corruption, fraud violations of civil and criminal law, and pervasive abuse of juvenile wards of the state, mental patients, and prisoners.
Dr. Kruszewski served as a medical-psychiatric consultant for the Dept. of Public Welfare charged with investigating the state's medical assistance program to prevent provider fraud, waste and abuse until 2003, when he was fired because (he claims) he uncovered major abuses implicating the giants of the pharmaceutical industry.
Dr. Kruszewski discovered that "four children and one adult who had been prescribed potentially lethal combinations of medications died while under state care." He believes they died from drug toxicity, but he was not permitted to review the autopsy reports. The suit blames "aggressive marketing practices by some of the nation's largest drug manufacturers."
This is the second whistleblower suit in Pennsylvania charging pharmaceutical companies and state officials with fraudulent promotion and misuse of psychotropic drugs. [See below] Dr. Kruszewski charges Pfizer, Johnson & Johnson, Novartis AG, AstraZeneca PLC, GlaxoSmithKline, and Eli Lilly of having used their political influence "capitalizing on intimate relationship between the current President of the United States, George W. Bush, and then Governor of Pennsylvania, Thomas Ridge" to aggressively promote the expansive use of psychotropic drugs.
Dr. Kruszewski, who received his medical degree from Harvard, challenges the widespread misuse of psychotropic drugs in the state system mental health system, state correctional system, and Juvenile welfare system in Pennsylvania "and other states." Dr. Kruszewski points out the indiscriminate misuse of psychotropic drugs in these institutionalized people is "unsupported by clinical studies or any viable evidence to support their recommended use." The drugs whose use he disputes include Neurontin, Paxil, Geodon, Risperdal, Seroquel, Topamax, Trileptal and Zyprexa.
Another whistleblower suit by Dr. David Franklin was settled in May when Pfizer admitted to criminal charges in the promotion of Neurontin, paying $430 million in settlement. [See: Pfizer Case Signals Tougher Action On Off-Label Drug Use By DAVID ARMSTRONG and ANNA WILDE MATHEWS THE WALL STREET JOURNAL May 14, 2004; Page B1
In addition to "Off-label" use of medications, Dr. Kreuszweski's suit charges misuse of medications on innocent human beings; over medication of adults and children; deaths of children under the care of the Pennsylvania; fraudulent billing of...Medicaid...and fraudulent billing of the US government for medications and in-hospital and other clinical care; mistreatment of children resulting in deaths in Pennsylvania, Texas, and Oklahoma; illegal use of Pennsylvania involuntary commitment law; mistreatment of Hispanic citizens; the intentional dissemination of misinformation through physician handbooks; and the improper adoption of drug company sponsored TMAP [Texas Medication Algorithm Program] in [the Department of Public Welfare], and state correctional systems.
TMAP is the focus of another whistleblower suit by Allen Jones, formerly with the Pennsylvania Office of Inspector General, that promises to blow the lid on pharmaceutical industry influence on state mental health practice guidelines. See "Making Drugs, Shaping the Rules," in The New York Times, Melody Petersen, on the front page of the Business section, February 1, 2004; Whistleblower Removed From Job, by Jeanne Lenzer, British Medical Journal, May 15, 2004 http://bmj.bmjjournals.com/cgi/content/full/bmj;328/7449/1153 Full report by Allen Jones at: http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf,
Of note, The Times reports that Thomas Scully, former director of Medicare who concealed the projected cost of the Medicare Prescription Drug program from Congress, to ensure its passage, "has registered as a lobbyist for major drug companies, including Abbott Laboratories and Aventis; for Caremark Rx, a pharmacy benefit manager; and for the American Chiropractic Association and the American College of Gastroenterology, among other clients. All are affected by the new Medicare law, which Mr. Scully helped write."
Contact: Vera Hassner Sharav Tel: 212-595-8974 e-mail: veracare@ahrp.org
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting openness and full disclosure
http://www.ahrp.org
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Dr. Stefan Kruszewski, a prominent Harrisburg psychiatrist who was hired to root out fraud, abuse and waste within the state's Department of Public Welfare, was fired for doing just that, he alleges in a federal lawsuit.
During the course of his duties, Kruszewski discovered that four children and one adult who had been prescribed potentially lethal combinations of medications died while under state care, he said. He believes they died from drug toxicity, but he was not permitted to review the autopsy reports, he alleges.
He also found that thousands of psychiatric patients on Medicaid and receiving inpatient treatment in hospitals across the state were being given bizarre combinations of drugs they did not need or were given the wrong drugs for their conditions, he said. In Philadelphia, employees of one facility, which he would not name but which he recommended be shut down, were going into the community and dragging in heroin and crack addicts, involuntarily committing them and prescribing all sorts of anti-depressants and anti-anxiety medications they didn't need, he said.
"I told my supervisor, 'These medications are killing people. Something's wrong here,' Then they fired me,' " said Kruszew-ski, 53, a Harvard Medical School graduate, in an exclusive interview yesterday .
Kruszewski's federal whistleblower lawsuit was filed in Harrisburg on Friday. The defendants are: state Welfare Secretary Estelle Richman; Susan Kozak, Kruszewski's former supervisor; Christopher Gorton, another supervisor who no longer works there; Columbus Medical Services LLC, the company that hired him, and two of its executives; and pharmaceutical companies GlaxoSmithKline; Pfizer, Inc.; Johnson & Johnson; Novartis; Astrazeneca and Eli Lilly & Co. The drugs at issue are Paxil, Neurontin, Geodon, Risperdal, Seroquel, Topamax, Trileptal and Zyprexa.
The lawsuit makes a number of stunning accusations against the state and the companies, alleging that they had abused Pennsylvania's involuntary-commitment law, overmedicated patients, distorted statistics, violated regulations and advisories, including Food and Drug Administration rules, and intentionally exaggerated and misrepresented the effects of the drugs on "innocent persons, simply to make money."
The defendants either did not return phone calls requesting comment or said they had not yet seen the lawsuit so they could not comment on it. Kruszewski said he has documented all his findings. "The evidence I have is absolutely black and white," he said. "Copies of the documents have been made and are in safekeeping in multiple places." Former state auditor general Don Bailey, Kruszewski's attorney, also represents Allen Jones, a former investigator for state Inspector General Donald L. Patterson, whose agency is supposed to ferret out corruption within other state agencies.
Jones began digging into the financial link between pharmaceutical companies and state health officials and said he soon discovered that drug companies were influencing those officials with trips, perks, lavish meals, transportation to and from first-class accommodations in major cities, he said. Some officials were given $2,000 honorariums by the drug companies for speaking in their official capacities at drug-company sponsored events, he said. Jones' boss pulled him off the probe but said he could continue it on his own time. Jones was fired last month after speaking to the media about his findings. He has two lawsuits pending against the state.
Jones said yesterday that he met Kruszewski only recently, through Bailey. "It is very interesting that Stefan [Kruszewski] and I came upon different tentacles of the same beast within the PA mental health system and were both fired for trying to expose the corruption," he said. "Meanwhile, the corrupted officials are still in their jobs."
Jones said he had warned the inspector general, in writing, that deaths of innocent people were a statistical certainty. "He refused to consider my concerns," Jones said. "I believe the office of inspector general and the governor himself share in the moral responsibility for the deaths and injuries Stefan has uncovered."
Kate Philips, Gov. Rendell's spokeswoman, declined to comment, citing the pending litigation. Amy Wasserleben, Inspector General Patterson's spokeswoman, could not be reached for comment.
Bailey, Kruszewski and Jones' attorney said a clear pattern was emerging of lawmakers and state officials' allowing financial kickbacks from pharmaceutical companies to influence their decisionmaking. "[Jones'] supervisor told him, 'Drug companies not only write checks to hospitals, they write checks to politicians...They write checks to both sides of the aisle,' " Bailey said, adding that the supervisor had admitted making those comments in his deposition for one of Jones' lawsuits. "There's billions and billions of dollars involved here, and we are talking about the most insidious profiteering imaginable," Bailey said. "If we cannot find an honest federal prosecutor to convene a grand jury to look into some of these things, like the deaths, then we are in a crisis."
Kruszewski was hired on Oct. 9, 2001, by the Columbus organization in King of Prussia to do work for the state Department of Public Welfare. He was paid $15,000 per month. Half his job was conducting medical reviews and appeals for the department. The other half was working as a medical-psychiatric consultant for the department's Bureau of Program Integrity. Its mission is to ensure that the state's medical-assistance program is protected from provider "fraud, waste and abuse," the lawsuit notes.
"I was told [by Kozak, Kruszewski's former supervisor] never to look at the medications in judging quality of care," Kruszewski said. "The trouble is you can't do your job and ignore the medications." The first disturbing trend he noticed was that an overwhelming number of psychiatric patients were being prescribed Neurontin, an anti-seizure drug, to treat illnesses like anxiety, depression, psychosis and impotence, he said. The FDA has not approved using that drug for mental illnesses, he said.
The more he dug, the more disturbing cases he found, he said, including that of a mentally retarded 15-year-old girl who was being treated for being defiant and for sexual promiscuity. She was on 11 medications, including five anti-psychotic ones, but did not have a psychiatric disorder, he said, and was so overmedicated she had trouble getting out of bed or standing by herself. "I said, 'This is more than just craziness. This is criminal,' " he said. "This makes no sense. You couldn't pay enough to get any psychiatrist in the country to say this is reasonable medication." Last July 10, he brought this case and others to his supervisors, Kozak and Gorton. They blasted him for "digging up dirt" then fired him the next day, saying he'd verbally harassed and physically intimidated Kozak, he said.
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