Jul 1, 2010
By David Voreacos

U.S. Senator Charles Grassley asked 16 drugmakers, including Pfizer Inc., AstraZeneca Plc and Eli Lilly & Co., to reveal how they treat whistleblowers who file complaints under the False Claims Act.

Grassley, an Iowa Republican, sent letters June 28 that posed eight questions such as how companies notify employees of the law, how they treat whistleblowers and what changes they have made in response to a 2009 law extending anti-retaliation protections. Grassley’s office provided copies of the letters.

The False Claims Act lets private citizens sue on behalf of the government and share in any recovery. Whistleblowers were paid $2.39 billion from 1987 to 2009, or 16 percent of the $15.19 billion collected in False Claims lawsuits in which the U.S. government joined the case, according to the Justice Department.

“What measures does Pfizer have in place to ensure fair treatment to those filing complaints?” Grassley wrote to Chief Executive Officer Jeffrey Kindler. “Of employees who have filed complaints, have any complained of unfair treatment and/or retaliation after the filing of the complaint?”

The False Claims Act was passed by Congress in 1863 and strengthened three times since 1986. Citizens file so-called qui tam cases that remain sealed from public view as the Justice Department investigates the claims and decides whether to join the suit. Twenty-five U.S. state shave their own versions of the law.

Large Settlements

Drugmakers have reached some of the largest settlements in recent years. Pfizer agreed to pay $2.3 billion over improper drug marketing, Lilly paid more than $1.6 billion to settle claims over its marketing of the drug Zyprexa, and AstraZeneca paid $520 million over marketing of its drug Seroquel.

Chris Loder, a spokesman for New York-based Pfizer, the world’s biggest drugmaker, said the company is responding to the letter and “shares the senator’s desire to detect and report any false claims that may lead to unnecessary costs to our health-care system.”

Pfizer, he said, has invested “substantial resources” to “create a compliance program that consists of mandatory training for every one of our employees, proactive monitoring and surveillance, and strict enforcement of all federal and state health-care laws.”

The company also has a chief compliance officer reporting to the CEO, a corporate compliance committee, a code of conduct, a compliance hotline and extensive procedures to investigate and remediate possible non-compliance, he said.

Anonymous Reports

Tony Jewell, a U.S. spokesman for London-based AstraZeneca, the U.K.’s second-largest drugmaker, said the company encourages its employees to report any instances of misconduct through various channels, including anonymously.

“We respond to all complaints of wrongdoing through prompt investigations and appropriate remedial action,” he said. “Retaliation of any kind is explicitly prohibited under our policies.”

Edward Sagebiel, a spokesman for Indianapolis-based Lilly, confirmed that the company received the senator’s letter.

“We will be cooperating fully with this request for information,” he said.

Grassley was a sponsor of the Fraud Enforcement and Recovery Act passed last year, which restored powers under the False Claims Act that had been narrowed by court rulings. The new law limited the ability of companies to avoid liability under the False Claims Act and made it easier for the Justice Department to issue civil investigative demands, a type of subpoena power, in pursuing cases.

‘Public Responsibility’

“My appeal to drugmakers is based on the fact that they have a public responsibility to safeguard the tax dollars that pay for their products, and promoting a culture where those who speak up about possible fraud are rewarded rather than retaliated against is one way to fulfill that responsibility,” Grassley said in a statement. “There can never be too many taxpayer watchdogs, so I see this letter as an opportunity to foster a mindset that recognizes the value of whistleblowers and the duty these companies have to act honestly when seeking taxpayer dollars.”

Whistleblowers are routinely exposed to retaliation and blackballing from their industries, said Patrick Burns, a spokesman for Taxpayers Against Fraud, a Washington non-profit advocate for the False Claims Act.

“The goal for companies is to isolate, humiliate, and terminate,” Burns said. “They want to send a signal to anyone else in the company that this is what happens to you — you will lose your job, you may lose your house, you may end up with a dissolved marriage.”

The Justice Department is investigating almost 1,000 whistleblower cases filed under seal, Assistant Attorney General Tony West said in an interview on June 3.

In the letters, Grassley, the ranking Republican member of the Senate Finance Committee, said he expects written responses to his questions by July 20.

December 31, 2009
By Richard E. Vatz and Jeffrey A. Schaler

The vast majority of Americans are unaware of most of what is included in the Senate and House health care reform bills as they head for reconciliation in the House-Senate Conference. They will be in for a big surprise concerning parity mental health care coverage, covering mental problems comparably to physical problems. In addition, the arguments supporting the changes, rarely made public in order to avoid rigorous debate, have revealed the shifting grounds supporting parity.

Health and Human Services Secretary Kathleen Sebelius spoke on Dec. 16 to a friendly crowd of health care providers and others at Sheppard Pratt Health System near Baltimore, a location for a broad array of psychiatric services, concerning mental health coverage, and, according to reports, she defended the expansion of such coverage with all of the familiar shibboleths.

She argued, consistent with the administration’s claim that expanding health care in general to 30 million or more citizens would actually save us money, that the vastly increased mental health parity program would additionally, as the Baltimore Sun reported her message, “improve care for millions of Americans who do not get all the mental health services they need.”

In the speech, Ms. Sebelius said, “One in 5 Americans will have a mental health illness this year and almost half will have a mental illness in their lifetimes. Yet 10 million people didn’t get the mental health care they needed last year, and 20 million didn’t get substance abuse services.”

Ms. Sebelius proclaimed her own false analogy of mental health to physical health by saying, “If 10 [million] or 20 million Americans were walking around bleeding, we’d have alarm bells going off.”

But if mental heath professions’ own estimates of the current number of people who are mentally ill are correct, Ms. Sebelius is way off in her calculations. As Mark Twain quipped, “There are lies, damned lies and statistics.”

The American Psychiatric Association (APA) claims that more than 50 percent of Americans are mentally ill in their lifetime – and recent APA studies dwarf that statistic. Moreover, the problems that qualify as “mental disorders,” all those listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), are virtually without limit.

Significantly, the new coverage of mental illness covers a vast array of the “worried well,” who have no neurological or mental disorders but simply have problems in living. Support for mental health parity in the new health reform bills relies on the public’s false inference that the prototypical mental disorder is dementia or some other organically based brain disease, which constitute only a tiny percentage and atypical sampling of the hundreds of “mental disorders” listed in DSM-IV.

Typically, psychiatrists label those unhappy people they concede have no physical illness as having “social anxiety disorder” or some other equally benign “disorder.” Such people can be in costly, insurance-covered therapy indefinitely. As one psychologist told us, “Anyone who comes in with any problem can be diagnosed as having ‘adjustment disorder.’ ” (e.g., “with anxiety,” DSM-IV Code 309.24).

There are many such diagnoses of easily applicable disorders, including “antisocial personality disorder” (DSM-IV Code 301.7), “avoidant personality disorder” (DSM-IV Code 301.82), and others vague enough to be applied to almost anyone. This is one of the reasons that the American Psychiatric Association claims that in a lifetime far more than a majority of citizens will suffer from a mental disorder, and the estimates are increasing.

In the December 2008 APA’s Archives of General Psychiatry, there is a report that “almost half of college-aged individuals had a psychiatric disorder in the past year [emphasis added],” and this includes heavy drinking, categorized as “alcohol use disorder” (DSM-IV Code 305.00).

When everyone is sick, what is normal? “What is healthy?”
On one strategy to deal with these issues, perhaps Ms. Sebelius and mental health skeptics can agree: It is high time to let a national debate begin – before mental health parity becomes part of universal national health care insurance.

Richard E. Vatz, a professor at Towson University, is associate psychology editor of USA Today Magazine. Jeffrey A. Schaler, a professor at American University, is executive editor of Current Psychology and author of “Addiction Is a Choice” (Open Court Publishing Co., 1999).

By Gardiner Harris, New York Times
October 21, 2009

Drug Makers Are Advocacy Groups’s Biggest DonorsWASHINGTON — A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations. Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

“For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,” Mr. Fitzpatrick said.

He promised that the industry’s share of the organization’s fund-raising would drop “significantly” next year.

“I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,” Mr. Fitzpatrick said. “It’s simply not true.”
Mr. Fitzpatrick said Mr. Grassley’s scrutiny, which he described as understandable given the attention paid to potential conflicts of interest in medicine, had led his organization to begin posting on its Web site the names of companies that donate $5,000 or more. And he predicted that other patient and disease advocacy groups would be prodded by Mr. Grassley’s investigation to do the same.

“Everyone I talk to wants to have more balanced fund-raising,” Mr. Fitzpatrick said. In a statement, Mr. Grassley praised the alliance for its disclosures. “It’d be good for the system for other patient groups to do what NAMI has done,” he said.

Mr. Grassley’s scrutiny has been unnerving for patient and disease advocacy groups, which are often filled with sincere people who are either afflicted with serious illnesses themselves or have family members who have been affected. Many join the groups in the hope of making sense of their misfortune by helping to find a cure or raising awareness of a disease’s risks and frequency.

Drug makers are natural allies in these pursuits since cures may come out of corporate laboratories and the industry’s money can help finance public service campaigns and fund-raising dinners. But industry critics have long derided some patient organizations as little more than front groups devoted to lobbying on issues that affect industry profits, and few have come under more scrutiny for industry ties than the mental health alliance.

For years, the alliance has fought states’ legislative efforts to limit doctors’ freedom to prescribe drugs, no matter how expensive, to treat mental illness in patients who rely on government health care programs like Medicaid. Some of these medicines routinely top the list of the most expensive drugs that states buy for their poorest patients.

Mr. Fitzpatrick defended these lobbying efforts, saying they were just one of many the organization routinely undertook. The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

“For the past five years, Bristol-Myers has sponsored this dinner at the highest level,” Dr. Feinstein said. He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that “now, more than ever, our enduring relationship with NAMI must remain strong.”

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits. The documents show, for example, that the alliance’s leaders, including Mr. Fitzpatrick, met with AstraZeneca sales executives on Dec. 16, 2003.

Slides from a presentation delivered by the salesmen show that the company urged the alliance to resist state efforts to limit access to mental health drugs.

“Solutions: Play Hard Ball,” one slide was titled. “Hold policy makers accountable for their decisions in media and in election,” it continued.

The alliance’s own slides concluded by saying, “We appreciate AstraZeneca’s strong support of NAMI.” Mr. Fitzpatrick said that the alliance frequently had such meetings and that the organization would fight for better access to mental health drugs “even if we had no relationship with pharmaceutical companies.”

Tony Jewell, an AstraZeneca spokesman, said that the company was “committed to improving health through partnerships with nonprofit organizations” and that “includes striving to ensure people can access our medicines through formularies managed by state Medicaid agencies.”

By Nicole Gaouette
April 6, 2009

U.S. Senator Charles Grassley expanded his investigation into drug company influence on the practice of medicine by asking a nonprofit mental-health-advocacy group about its funding.

In a letter sent today to the National Alliance for Mental Illness, based in Arlington, Virginia, Grassley asked the nonprofit group to disclose any financial backing from drug companies or from foundations created by the industry. The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions. His efforts have led New York-based Pfizer Inc. to begin disclosing consulting payments to U.S. doctors, and Harvard Medical School in Boston to reexamine its conflict-of-interest policies. Now Grassley is expanding his inquiries to nonprofit groups.

“I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions,” Grassley wrote in his letter. Officials at the National Alliance for Mental Illness didn’t return calls for comment. The group identifies itself as the largest grassroots organization in the U.S. for people with mental illness and their families. The group came under scrutiny in 1999, when the magazine Mother Jones reported that 18 drug companies gave the group $11.7 million from 1996 to mid-1999. The article reported that at one point an executive of Indianapolis-based Eli Lilly & Co. worked out of the nonprofit group’s headquarters.

A 2007 annual report showed that the group’s corporate partners at that time included Madison, New Jersey-based Wyeth; London-based GlaxoSmithKline Plc; Eli Lilly, which makes Prozac; and the Washington-based trade group Pharmaceutical Research and Manufacturers of America.

Financial Report

A separate financial report shows the National Alliance for Mental Illness brought in $10.5 million in contributions in the year that ended June 30, 2007. The donors aren’t broken out.

Vera Sharav, president of the Alliance for Human Research Protection, a New York-based nonprofit that promotes ethical research, said the National Alliance for Mental Illness may have drawn Grassley’s attention because it lobbies Congress for mental-health funding.

“Academics and physicians give an appearance of authority,” Sharav said by telephone. “Industry gives them the money. Grassley has been going after each group systematically, and the dots are being connected.”

In January, Grassley and Senator Herb Kohl, a Wisconsin Democrat, reintroduced the Physician Payment Sunshine Act, which would require manufacturers to report on payments to doctors and any physician-owned facility.

Pfizer Announcement

Grassley’s investigations have led to changes in industry and academia. Pfizer made its announcement about disclosing physician payments in February. In March, the American Psychiatric Association said it would no longer accept industry support for symposiums and meals at its annual meetings.

On April 1, Stanford University School of Medicine, near Palo Alto, California, said it would post on a Web site all income faculty earned from royalty payments and outside consulting.

In the March 31 issue of the Journal of the American Medical Association, a group of researchers and physicians called for professional medical associations to transform their operations to avoid conflicts of interest posed by “extensive funding from pharmaceutical and device companies.” The group included Steven Nissen, a Cleveland Clinic cardiologist.