Philadelphia Daily News
Pharma Influence: Penn Psychiatrist Files Whistleblower Lawsuit – Investigtion Confirms Medicare Chief Lied to Congress
Wed, 7 Jul 2004
“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. Kruszweski’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
Philadelphia Daily News
Lawsuit: State fired shrink for exposing abuse
By NICOLE WEISENSEEEGAN
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 Kruszewski, 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.
THE NEW YORK TIMES
July 7, 2004
Inquiry Confirms Top Medicare Official Threatened Actuary Over Cost of Drug Benefits
By ROBERT PEAR
WASHINGTON, July 6 – 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.
A report on the investigation, issued Tuesday, says the administrator of Medicare, Thomas A. Scully, issued the threat to Richard S. Foster while lawmakers were considering huge changes in the program last year. As a result, Mr. Foster’s cost estimate did not become known until after the legislation was enacted.
But neither the threat nor the withholding of information violated any criminal law, the report said. It accepted the Justice Department’s view that Mr. Scully had “the final authority to determine the flow of information to Congress.” Moreover, it said, the actuary “had no authority to disclose information independently to Congress.” Mr. Scully, who resigned in December, in part to become a lobbyist for health care companies, had denied threatening Mr. Foster but had acknowledged having told him to withhold the information from Congress.
The report, by Dara Corrigan, the department’s acting principal deputy inspector general, said, “Our investigation revealed that the Centers for Medicare and Medicaid Services did not provide information requested by Congressional members and staff, and that Scully threatened to sanction Foster if he disclosed unauthorized information.”
The report said that if Mr. Scully still worked for the government, he might be subject to disciplinary action for possible violation of the department’s standards of ethical conduct. But Ms. Corrigan discovered “no criminal violations,” though she sent her findings to the General Accounting Office, a Congressional investigative arm, to determine if Medicare officials had violated an appropriations law that protects the right of federal employees to communicate with Congress. In May, the Congressional Research Service said Mr. Scully’s order to Mr. Foster apparently violated that law, which has been on the books in various forms since 1912.
William A. Pierce, a spokesman for the department, said Tuesday that the threat was not illegal because the actuary was supposed to report to the head of the Medicare program, who, Mr. Pierce said, had a right to dismiss him in case of insubordination. “No laws were broken,” Mr. Pierce said.
But Representative Pete Stark of California, the senior Democrat on the House Ways and Means Subcommittee on Health, said, “It sounds as though the Bush administration examined itself and found it did nothing wrong.” The senior Democrat on the Senate Finance Committee, Max Baucus of Montana, said that given a limited scope of the investigation, “we cannot know about the involvement or knowledge of White House officials” in the suppression of information.
When President Bush signed the Medicare bill on Dec. 8, he hailed it as “the greatest advance in health care coverage for America’s seniors since the founding of Medicare” in 1965. Republicans were counting on the measure to help them win votes from the elderly in this year’s elections. But Democrats, including Senator John Kerry, the party’s expected presidential nominee, have waged a campaign to discredit the law, which they say is more helpful to drug companies and insurers than to elderly and disabled people.
The internal investigation was ordered by Tommy G. Thompson, the secretary of health and human services, on March 16, four days after House Democrats requested such an inquiry, and nearly four months after Congress approved the Medicare overhaul. In recent weeks, Mr. Scully 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.
Mr. Scully did not reply to messages left Tuesday at his office and his home and on his cellphone. In an interview in March, he acknowledged disagreements with Mr. Foster but said, “I never told Rick he would be fired.” Mr. Foster had estimated that the Medicare legislation would cost $500 billion to $600 billion over 10 years. The White House told Congress the cost would not exceed $400 billion.
Ms. Corrigan said she had uncovered numerous requests from Congress for data and cost estimates prepared by the Bush administration. In many cases, she said, Mr. Scully did not recall the requests. “On June 17 and Nov. 7, 2003,” the report said, “the minority staff director for the House Ways and Means Subcommittee on Health made written requests to Foster for estimates of the total cost of the Medicare bill. Scully did not recall the staff director’s requests.”
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