Posts Tagged ‘Senator Charles Grassley’

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Grassley & Senate Watchdog Target Doctors Prescribing Mass Amounts of Dangerous Drugs

Tuesday, January 24th, 2012

ProPublica
By Charles Ornstein and Tracy Weber
January 24, 2012

An influential U.S. senator is grilling officials in nearly three-dozen states, demanding to know how they are cracking down on physicians who prescribe massive amounts of potentially dangerous prescription drugs.

Iowa Republican Charles Grassley sent letters to 34 states Monday asking what steps they had taken to investigate doctors whose prescribing of antipsychotics, anti-anxiety drugs and painkillers to Medicaid patients far exceeds that of their peers.

The request is a follow-up to a 2010 letter Grassley sent all states that requested statistics on top prescribers of these drugs.

“These types of drugs have addictive properties, and the potential for fraud and abuse by prescribers and patients is extremely high,” Grassley wrote in Monday’s letters. “When these drugs are prescribed to Medicaid patients, it is the American people who pay the price for over-prescription, abuse, and fraud.”

ProPublica reported in November that Florida allowed at least three physicians to keep treating and prescribing drugs to the poor amid clear signs of possible misconduct. One doctor kept prescribing narcotic pain pills to Medicaid patients for more than a year after he was arrested and charged in 2010 with trafficking in them.

A number of the top-prescribing Medicaid doctors around the country are listed in our Dollars for Docs database of payments made by 12 pharmaceutical companies to physicians for speaking and consulting Medicaid, jointly funded by the states and federal government, provides health care coverage to about 60 million low-income enrollees.

Grassley, the senior Republican on the Senate Judiciary Committee, has long argued for greater transparency in health care. The painkillers and mental health drugs Grassley is inquiring about are among the top drivers of Medicaid drug spending.

His letter to Ohio notes that the top prescriber of the anti-psychotic Abilify wrote 13,825 prescriptions in 2009 — about 54 prescriptions per weekday. Ohio paid $6.7 million for that those prescriptions, state officials reported to Grassley.

The biggest prescriber of another anti-psychotic, Seroquel, wrote 18,890 scripts at a cost of $5.7 million. Grassley wrote the tally would amount to nine prescriptions per hour. When Ohio submitted the data to Grassley last year, it did not identify the doctors by name or license number.

“After an extensive review of prescribing habits of the serial prescribers of pain and mental-health drugs in Ohio, I have concerns about the oversight and enforcement of Medicaid abuse in your state,” he wrote. “While I am sensitive to the concerns of misinterpretation of the data you provided, the numbers themselves are quite shocking.”

Grassley’s letter to Maine cites a physician who wrote 1,867 prescriptions for the powerful painkiller OxyContin in 2009, nearly double the second-highest prescriber. The doctor also wrote 1,723 prescriptions for another painkiller, Roxicodone, nearly three times as many as the next highest prescriber.

Calls to officials in Ohio and Maine have not been returned.

In his letters to the 34 states, Grassley asked that officials tell him by Feb. 13 what action, if any, they have taken against top prescribers, whether those doctors are still eligible to bill Medicaid, whether any of the doctors were referred to their state medical boards for investigation, and what systems have been set up to track possibly excessive prescribing, among others.

Grassley is sending letters to 12 other states that never provided him data, as requested, on their top Medicaid prescribers. Four other states will not receive follow-up letters because the senator felt their initial responses to his 2010 letter were adequate.

ProPublica reported in November that since Grassley’s initial letter requesting the data in 2010, Louisiana, Arizona, Oklahoma and New York have kicked some high-prescribing physicians out of Medicaid. California has temporarily suspended or placed restrictions on 15 to 20 doctors in the past two years for prescribing disproportionately high volumes of painkillers and antipsychotics to Medicaid patients.

But Grassley said more needs to be done.

“When a doctor writes more prescriptions than seems humanly possible, it makes sense to ask questions,” he said in a statement to ProPublica. The statement noted that some states never responded to his original letter in 2010.

“If state and federal taxpayers are being cheated because of inappropriate prescriptions,” Grassley said, “the state and federal governments have to get to the bottom of it and stop it.”

Read article here:  http://www.propublica.org/article/senate-watchdog-targets-high-prescribing-medicaid-docs

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U.S. to Force Drug Firms to Report Money Paid to Doctors

Monday, January 16th, 2012

The New York Times – January 16, 2012

by Robert Pear

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul. “The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Federal officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.

The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.

Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.

Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”

In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”

The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.

“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.

“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.

Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.

Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.

As an example of inappropriate payments, the inspector general of the Department of Health and Human Services cited a case in which manufacturers of medical devices had provided financial incentives — in the form of consulting agreements, lavish trips and other perks — to induce doctors to use particular hip and knee replacement products. Under a civil settlement with the government, the companies agreed to new compliance procedures.

The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.

The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.

http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=2&pagewanted=all

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Doctors rarely face consequences for drug kickbacks

Tuesday, September 20th, 2011

The News Tribune – September 20, 2011
by Tracy Weber and Charles Ornstein; ProPublica

Despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians

Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits.

But a doctor named as a co-defendant in one suit – for allegedly taking kickbacks to prescribe the drug extensively at nursing homes – never was pursued.

Last year, Alpharma paid $42.5 million to settle federal allegations that it paid kickbacks to doctors to prescribe its painkiller Kadian.

“Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” Rod Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement.

But the doctors, accused of trading prescriptions for paid speaking gigs, faced no consequences.

At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants was sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.

Reporters reviewed hundreds of pages of court records and interviewed current and former federal prosecutors, state medical board officials, attorneys for whistle-blowers and, when possible, the doctors. For each doctor identified in a suit, ProPublica checked for state medical board discipline, penalties from the Medicare program and federal criminal charges.

In many of the cases, it appears that not even a cursory investigation was done to see whether the physicians had behaved inappropriately.

“Doctors have kind of gone under the radar,” said Tavy Deming, a Philadelphia lawyer who represents drug company whistle-blowers.

Amid concerns about the influence of drug company money on medicine, whistle-blower lawsuits have emerged as a headline-grabbing tool for holding manufacturers accountable.

Yet, despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians. Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits. And even when settling, many companies, including Alpharma, continue to deny the allegations.

After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians’ behavior. Patients have no way of knowing whether their doctor’s judgment has been compromised, and doctors might be tarnished by spurious accusations.

Medical boards, which normally pursue tips or complaints of wrongdoing, do not routinely scan for such cases. Justice Department lawyers, wary of spending more time and effort on a case, say they usually are not interested in going after lesser players.

Tony West, the assistant attorney general who oversees civil litigation nationwide for the Justice Department, declined through a spokeswoman to discuss the issue. In announcing settlements with the drug companies, however, West has said that kickbacks undermine doctors’ credibility. Medical decisions, he said in one news release, should be “guided by a patient’s needs, not tainted by illegal incentives or fraud.”

Sen. Charles Grassley, Iowa, the ranking Republican on the Judiciary Committee, said in a written statement that it takes “two sides to perpetuate this fraud” and that both need to be held accountable.

“Otherwise, regardless of how big of a civil settlement a drug company makes, the incentive to cheat the taxpayers will still be in place for those willing to take part,” said Grassley, who has led investigations into conflicts of interest in medicine.

In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits detailing how the pursuit of profit allegedly fueled fraud and corruption.

The suits are typically filed by former employees who say the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions – even billions – of dollars spent on these products by government health programs.

For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves a trail of incriminating email and memos.

The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits. Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010. Kadian, Alpharma’s painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.

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US health agency revises conflict of interest rules

Tuesday, August 23rd, 2011

From Project on Government Oversight:

In recent years, Senator Grassley exposed several academic physicians for taking large amounts of money from companies with a direct financial interest in their research, some of it funded by the NIH. The list reads like a who’s who in academic research:

    • Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant.  Dr. Nemeroff was bounced from Emory and has now taken over the Chair of Psychiatry at the University of Miami.
    • Dr. Alan Schatzberg, former Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. An NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.”  The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.
    • Dr. Joseph Biederman and two other researchers at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard later disciplined the three physicians.

US health agency revises conflict of interest rules

From Reuters – August 23 – 2011

by  Alina Selyukh

WASHINGTON,  – The U.S. National Institutes of Health revised on Tuesday its 16-year-old conflict of interest rules for medical researchers, lowering the amount of money that constitutes a financial conflict and expanding the required disclosures.

The 1995 regulations effectively put responsibility for tracking scientists’ financial conflicts of interest on their universities. The rule required researchers to disclose conflicts to their institutions, which then had to assure the NIH the conflict had been managed, reduced or eliminated.

The new rule extends that requirement so researchers report not only the fact of a conflict of interest, but also its details such as value, specific nature, why it is a conflict and the impact it might have on research.

It lowers the amount a researcher must disclose if received from an industry or held in company stock to $5,000 from about $10,000.

Research institutions, in turn, are now required to report that information to the federal grant-awarding agency alongside details of how the conflicts are managed. Also, before spending any grant money, the institution has to post information about the financial conflicts on a public website.

The new rules will affect about 2,000 organizations that are awarded public health science funding every year and some 38,000 scientists who participate in research funded by these grants and have a “significant financial interest,” NIH said.

Concern about the integrity of research in the United States has grown since 2008, when Iowa Republican Sen. Charles Grassley criticized prominent Harvard University psychiatrist Dr. Joseph Biederman and others for failing to fully disclose payments from drug companies.

In a more recent example, medical device maker Medtronic Inc (MDT.N) came under fire over accusations that doctors paid by the company had failed to disclose major side effects from a bone growth drug in clinical trials.

A 2009 report by the Institute of Medicine, one of the National Academies of Sciences that advises U.S. policymakers, called on doctors to strictly disclose research funding to strengthen protection against conflicts of interest. The report called for virtually anyone involved in medicine — academic medical centers, journals, professional societies, researchers and doctors — to set up or strengthen conflict of interest guidelines.

From 1996 to 2007, relationships between individual academic researchers and industry nearly doubled, according to a study cited by NIH in its final rule. From 1994 to 2003, the amount of financial support for biomedical research almost tripled to $94.3 billion, with 57 percent of that funding coming from industry sources, according to analysis cited by NIH. (Additional reporting by Anna Yukhananov; editing by Andre Grenon)

http://www.reuters.com/article/2011/08/23/health-science-conflicts-idUSN1E77M1PB20110823

 

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Once Again Psychiatrists Top the List of Top Prescribers—And Are Heavily Funded by Pharma

Wednesday, December 8th, 2010

Note from CCHR:   The reason why we repeatedly see psychiatrists on the list of top drug prescribers is pretty simple.  It’s so easy to prescribe psychiatric drugs to patients. Think about it.  It’s not like cancer or diabetes, or even high cholesterol where there’s a test to show some disease or imbalance requiring “medication” to treat it.   Sure there are medical conditions that may not have a “test” to prove anything is wrong.  There are some.  But there are no tests to prove anyone has a mental disorder.  Not one.  So psychiatrists can make a killing when it comes to writing unnecessary prescriptions.  Literally.   All while raking in the bucks from Pharma.

San Diego Union Tribune – December 8, 2010

By Christina Jewett

Three San Diego doctors who prescribe medications at the same time they are paid by drug companies as experts on the products figure into a broader national debate about whether playing both roles poses a conflict.

California Watch, a project of the independent, nonprofit Center for Investigative Reporting, compared two sets of data at the center of the debate — one a database of payments by drug companies to doctors nationwide and the other a list of the top antipsychotic prescribers in California’s Medi-Cal program for the poor and disabled.

Among California’s top prescribers, three accepted more than $20,000 in educational or speaker’s fees from the company that makes the drug they prescribe to Medi-Cal patients. All three practice in San Diego County.

Accepting drug company payments and then prescribing the products to patients is not illegal or even unethical, in and of itself. But some inside the profession and out are concerned such marketing could induce over-prescription of drugs or otherwise corrupt the process.

Two of the San Diego-area psychiatrists share a La Mesa office — Samuel O. Etchie and John W. Allen.

Allen was among the state’s top prescribers of Zyprexa, an antipsychotic drug. Allen dispensed 418 prescriptions at a cost to the state of $346,569. This year and last, the drug’s maker, Eli Lilly and Co., paid him about $27,000 to educate other medical professionals.

Allen said he conducts speeches about Zyprexa for Lilly based on information contained in the FDA-approved literature that comes with the drug. He said he speaks for a variety of drugmakers if he has done research and treated patients with the medication.

“I think it’s unfortunate that there’s in implication in articles that we’re robots for drug companies,” Allen said. “We have to have our own experience with medications and find out what works best. We’re not 5-year-olds in front of TV watching cereal and toy commercials.”

Allen said the prescribing numbers reflect the many bipolar and schizophrenic patients he treats in his practice. He said he prescribes a wide variety of medications, new and old.

“Whatever works for the patient is most important,” Allen said.

Etchie, who shares and office with Allen, prescribed Seroquel more than 1,000 times in 2009 at a cost of $449,000 to the state, according to Medi-Cal records collected by the Pro Publica news organization and provided to California Watch. The drug’s maker paid him $25,350 this year to speak to health professionals.

Etchie said he’s been paid by drug companies to give talks for about 10 years, and sees it as a way to keep himself informed about new and approved uses for medications and to share that information with colleagues who may be too busy to keep track of the research themselves. He said his presentations on Seroquel are an overview of the research drugmaker AstraZeneca has given the FDA about the medication.

“Whatever I do in the area of medicine, I want to get paid,” he said. “But my motive in doing this is to keep my knowledge base current and then to pass on that information to colleagues. Whether a doctor prescribes a medication or not is none of my business. I’m not a salesman.”

The third San Diego-area doctor is Harinder Grewal, a child psychiatrist who sees patients throughout the county.

According to Medi-Cal records, she issued nearly 3,000 prescriptions for antipsychotic medications in 2009, half of them for the drug Seroquel. This year AstraZeneca, that company that sells the drug, paid her $21,600 to educate other health workers.

Grewal did not return calls from California Watch or The San Diego Union-Tribune.

Grewal was also among the state’s top prescribers of the antipsychotic medication Geodon. That drug’s maker, Pfizer, spent $3,750 to compensate Grewal for leading an educational forum.

The three doctors showed up on a list provided by Medi-Cal officials to Sen. Charles Grassley, R-Iowa, who is reviewing prescribing rates of psychiatric and pain medications nationwide.

Grassley’s investigation comes on the heels of numerous government lawsuits that have accused pharmaceutical companies of illegally marketing drugs beyond their approved uses. California authorities who provided the information to Grassley’s office warned against viewing the data as a sign of wrongdoing.

Read the rest of the article here:  http://www.signonsandiego.com/news/2010/dec/06/paid-drug-experts-also-prescribe-products/

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Miami Psychiatrist Who Wrote 96,685 Prescriptions for Psychiatric Drugs in 21 Months Prompts Calls for Federal Investigation

Wednesday, October 20th, 2010

Lexington Herald Leader, October 20, 2010

By MAR CABRA AND JOHN DORSCHNER

Based on the huge numbers of prescriptions written by a Miami psychiatrist, Sen. Charles Grassley, R-Iowa, is continuing to pressure federal officials to investigate why some doctors write stunning numbers of scripts for tax-funded Medicare and Medicaid programs.

In his latest volley, a letter sent Wednesday to Kathleen Sebelius, secretary for the U.S. Department of Health and Human Services, Grassley demanded exact answers to three pointed questions about what her department is doing to address the problem.

“The federal government has an obligation to figure out what’s going on here,” Grassley said in a statement e-mailed to The Miami Herald Wednesday. “The taxpayers are footing the bill, and Medicare and Medicaid are already strained to the limit. These programs can’t spare a dollar for prescription drugs that aren’t properly prescribed.

“The conclusion might be that there isn’t any fraud, but it’s important to reach a conclusion one way or the other and fix whatever is broken,” Grassley said.

In the Sebelius letter, Grassley said his concern was triggered by a “Florida provider who wrote 96,685 prescriptions for mental health drugs in a 21-month period.” The letter did not identify the provider, but state records confirm that it is Fernando Mendez-Villamil, a psychiatrist with an office on Coral Way.

State Medicaid records independently obtained by The Herald show that over a two-year period Mendez-Villamil wrote almost twice as many prescriptions for mental health drugs as the No. 2 Medicaid prescriber in the state.

Robert N. Pelier, attorney for Mendez-Villamil, said Wednesday he and his client learned about the letter only after receiving a call from The Herald. He said the psychiatrist tried to reach Grassley’s office when his prescription numbers were made public to give the proper context to the doctor’s prescription patterns and “why he is an intricate part in the community.” Pelier said he had not received a response from Grassley.

“What my client believes is that he’s been a victim of this health care debate,” the attorney said. “The majority of his prescriptions are expensive because they’re cutting-edge pharmaceuticals.”

Pelier said Mendez-Villamil has been recently terminated from the Medicaid program and is now seeing some patients for free. “We are pursuing legal action against AHCA Agency for Health Care Administration for the improper termination of doctor Mendez-Villamil from Medicaid,” he said. The lawsuit was filed late July.

Meanwhile Ryan Wiggins, spokesman for the Florida Office of the Attorney General, confirmed there is an ongoing investigation into Mendez-Villamil that involves “complicated issues of medical necessity … We cannot comment further at this time.”

Last December, Grassley’s office calculated Mendez-Villamil’s numbers meant “this physician wrote approximately 153 prescriptions each and every day, assuming he did not take vacations.”

Earlier this year, Mendez-Villamil told The Herald that he works long hours and often gives each patient four or five prescriptions, accounting for the large numbers.

In April, Grassley wrote to all state Medicaid agencies requesting data about certain mental health drugs. On Wednesday, Grassley’s office said the Florida provider identified by The Herald as Mendez-Villamil had the second-highest number of prescriptions in the nation for the generic form of Xanax in the data they analyzed.

The Wednesday letter also noted that the top Zyprexa provider in Florida wrote 1,356 prescriptions for 309 individuals in 2008 and 1,238 for 236 in 2009. The Herald independently verified from state data that this provider was Mendez-Villamil, and he wrote more than twice as many Zyprexa prescriptions as the No. 2 provider in the state.

“I want to be clear that none of the information provided suggests any illegal or wrongful behavior,” Grassley wrote. But such huge numbers “might also suggest overutilization or even health care fraud. The only way to determine veracity is through appropriate oversight by Health and Human Services and continued monitoring by the Congress and the Senate Finance committee.”

Read more: http://www.kentucky.com/2010/10/20/1488418/grassley-seeks-probe-into-numbers.html#ixzz12xQPjZzm

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The Troubling Link Between Big Pharma and the American Psychiatric Association

Tuesday, March 30th, 2010

The Faster Times
By Alison Bass
March 30, 2010

First the good news: The Physician Payment Sunshine Act is now law, signed by President Obama as part of the health care bill overhaul. Starting in 2012, drug and medical device companies must report all consulting, speaking and other payments to doctors and teaching hospitals in excess of $100 annually to the federal Department of Health and Human Services, which will post the payments on a public website. This is an important first step toward making transparent the pervasive financial ties between doctors who are studying or promoting specific drugs and medical devices and the companies that manufacture these products.

There is one significant loophole in the law: according to thefinal provisions, payments related to clinical trials or product development agreements for new products are allowed a publication delay of four years or until product approval, whichever comes first. So if a particular doctor is researching a drug that has not yet been approved for a specific condition, we will have to wait four years to find out whether he or she is on the drug company’s payroll. But at least the disclosure will eventually see the light of day, and patients who are prescribed the drug in question can seek a second opinion from a doctor who is not on the drug firm’s payroll and whose medical judgment can be trusted.

The Physician Payment Sunshine Act, however, only goes so far. While it covers doctors and teaching hospitals, it does not extend to all the advocacy groups and professional organizations that have substantial influence on over how particular illnesses are treated. For example, as I reported, the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness, received millions of dollars in funding from drug companies for years — a payola that no doubt spurred this group’s embrace of potent psychoactive drugs over alternative methods of treating mental illness.

And now, in the current Psychiatric Times, two Massachusetts researchers tear the veil off efforts by the American Psychiatric Association (APA) to hide industry funding of its two philanthropic arms — the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE). As Lisa Cosgrove and Harold Burszstajn report: “While the APA recently announced it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding” of APF and APIRE.

Read entire article:  http://thefastertimes.com/healthinvestigations/2010/03/30/the-troubling-link-between-big-pharma-and-the-american-psychiatric-association/

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Psychiatrists And Pharma: Undue Influence? Concern about corruption increasing…

Friday, March 26th, 2010

Pharmalot
By Ed Silverman
March 25, 2010

Two essays published in separate periodicals this week raise troubling questions about the extent to which psychiatrists may be unduly influenced by the pharmaceutical industry, and how this relationship may effect public trust in psychiatry. The upshot? The concern about corruption, or at least the appearance of corruption is palpable. Sigmund Freud would not be pleased. Interestingly, one of the authors is Tom Insel, the director of the National Institute of Mental Health.

For instance, Lisa Cosgrove and Harold Bursztajn write in Psychiatric Times that they looked at the two philanthropic arms of the American Psychiatric Association – the American Psychiatric Foundation and the American Psychiatric Institute for Research and Education – and found that APF’s 15-member board includes four high-level pharma execs that either make meds recommended by APA or are developing products targeted to treat mental disorders. Other board members include two more with industry ties and a senior vp at Fleishman Hillard, the public relations firm whose clients include six drugmakers.

APF’s corporate advisory council lists drugmakers, they continue, that contribute “significant funding” to APF and that make meds recommended in the APA’s clinical practice guidelines. Although it was not possible to discern the total amount of industry funding given to APF, in fiscal year 2008 APF lists 11 pharmaceutical companies and 1 medical device manufacturer that contributed monies; 6 of the companies are listed as giving $40,000 “and above” per year.

They go on to write that APIRE, like APF, doesn’t require disclosure of financial conflicts of interests, and that nine of 16 APIRE board members have ties to drugmakers. They also note current disclosure policies don’t require reporting of pooled industry money to academic departments, units, hospitals, and med schools. And because there is no independent monitoring of industry ties, they maintain “underreporting is very likely a problem. For example, one board member who reported ‘no disclosure’ in an APA publication was found to be on the speakers’ bureau of multiple pharmaceutical companies.”

Read entire article:  http://www.pharmalot.com/2010/03/psychiatrists-and-pharma-undue-influence/

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Citing public’s growing distrust of psychiatry, NIMH Chief says psychiatry must “Clean up our act”

Wednesday, March 24th, 2010

FiercePharma
By Tracy Staton
March 24, 2010

Is the new Journal of the American Medical Association a special issue on reform? It doesn’t stop with its demands for new publication standards. It’s also showcasing a rallying cry from National Institute of Mental Health Director Dr. Thomas Insel, who calls on his fellow psychiatrists to “clean up our act.”

In Insel’s estimation, psychiatry has grown too close to drugmakers. All the money flowing from pharma to psychiatrists and psychiatric researchers has created a “culture of influence,” he says, and psychiatrists need to rise above all that. He wants all financial ties between drugmakers and psychiatry to be disclosed, and for psychiatrists to take a step back from branded meds in favor of generic drugs and non-drug treatments such as talk therapy.

This is far from the first call for change in psychiatry. Over the past three years, congressional probes have repeatedly highlighted influential psychiatrists’ financial relationships with industry. In some cases, payments from drugmakers went undisclosed even though researchers were obliged to report them to their universities.

- read the JAMA extract

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Sen Grassley’s bill now requires public disclosure of ALL Pharma $$ to doctors— Top Psychiatrist calls for “Ethics Cleanup”

Tuesday, March 23rd, 2010

Associated Press
Carla K. Johnson
March 23, 2010

American psychiatrists need to break away from a “culture of influence” created by their financial dealings with the drug industry, the head of the National Institute of Mental Health said in a leading medical journal.

Dr. Thomas Insel stops short of calling researchers corrupt or asking them to stop taking money from drug companies. But he highlights a “bias in prescribing practices” that favors brand names drugs over cheaper generics and non-drug treatments. And he says the situation must change with new standards for transparency and full disclosure of psychiatry’s collaborations with industry.

“We can show the rest of medicine how to clean up our act,” Insel told The Associated Press. His commentary appears in Wednesday’s Journal of the American Medical Association.

His efforts got a boost Tuesday with the signing of the health care overhaul legislation which requires drugmakers and others to file annual reports to the government on their financial ties to doctors. The law requires reporting of gifts, entertainment, food, research money and other fees and grants. Consumer advocates applaud the “sunshine” provision because it also requires a database the public can search for their own doctors’ ties to industry.

“Transparency is the first step toward giving patients and the public the tools they need to evaluate those relationships,” said Allan Coukell, director of the Pew Prescription Project, a consumer health project of the nonprofit Pew Charitable Trusts.

Current National Institutes of Health rules on financial disclosure are confusing, Insel said. They allow researchers seeking federal funds to make their own judgments about what constitutes a significant financial interest, which they must report to their academic or research institutions. The rules also exempt disclosures of anything below $10,000 annually or 5 percent equity interest in a company. Insel is helping oversee a revision of the NIH’s rules, which date back to 1995.

Industry pays for much of the medical research in the United States and many scientists have financial relationships with drug and device makers. Researchers at many institutions are expected to fully disclose those ties to their universities, to the NIH and to the medical journals that publish their research.

Beginning in 2008, an inquiry by Sen. Chuck Grassley, R-Iowa, uncovered millions of dollars in unreported fees paid by drug industry to prominent researchers. The investigation prompted universities and NIH to reassess their conflict-of-interest policies.

When the Grassley inquiry accused seven psychiatrists of failing to report payments they received from drug companies, Insel, himself a psychiatrist, said he tried to determine whether psychiatrists were being targeted unfairly.

He found, instead, evidence that psychiatry may have more drug ties than other medical specialties. In Vermont, for example, which requires public disclosure of industry payments to doctors, psychiatrists receive more money from drug companies than do other types of doctors.

Psychiatric journals report slightly higher rates of industry funding of published studies than other medical journals. And one study found that 90 percent of the advisers who help write American Psychiatric Association guidelines had undisclosed financial ties to industry, Insel writes in JAMA.

Read entire article:  http://www.google.com/hostednews/ap/article/ALeqM5i0eFhYRg8tB3fLeCNO4Ka1IXc_9wD9EKIA103

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