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Opinion
''The withdrawal of drug-company money''
"In recent years, the pharmaceutical industry has been repeatedly (and rightly) excoriated for its shameless efforts to promote its products: Freebies handed out to doctors as inducements to prescribe particular drugs. Studies underwritten by drug companies with financial interests in the outcome published in prestigious journals. Lucrative consulting contracts given to National Institutes of Health scientists. To name just a few.
You would think that in the face of all the unpleasant scrutiny -- books on the industry's 'deceit' and 'greed,' congressional investigations, lawsuits and even some criminal convictions -- drug makers would wake up, do some serious self-analysis, retool their outrageous marketing practices and try, as Pfizer Chief Executive Jeffrey Kindler said last month, to "earn the trust of patients and the public."
But this week, two New York Times stories suggested that, despite rhetoric to the contrary and a few tentative efforts at self-policing, the industry is still up to its old tricks. On Wednesday, the Times reported that federal prosecutors and health officials are planning to crack down on illegal drug-company kickbacks to physicians. As they should. These payments line doctors' pockets while driving up the cost of care and doing nothing -- or worse -- for patients.
The second story chronicled the anger of Harvard Medical School students over professors who receive drug industry consulting and speaking fees. About 1,600 of the school's professors and lecturers -- charged with molding the minds of aspiring doctors -- acknowledged that they or a relative had a financial interest in a business related to their teaching, research or clinical care; 149 had ties to Pfizer, and 130 to Merck.
The industry must be brought under control. But how? Its lobbyists are among the most powerful in Washington. Its revenues, though battered, remain enormous. Its voluntary measures have been largely symbolic or merely attempts to forestall tougher requirements imposed from outside. Yes, Pfizer and Eli Lilly recently unveiled new disclosure rules, and yes, the industry has tightened its ban on trinkets, fancy meals and other gifts -- but these are only a start.
Outsiders must keep the pressure on. An investigation by Sen. Charles E. Grassley (R-Iowa) has identified doctors who have failed to disclose large payments from drug firms. The crackdown by prosecutors is also welcome. In addition, the medical profession and academia need to wean themselves off inappropriate drug company money and ensure that their conflict-of-interest policies are loophole-free. Inevitably, some drug money will still flow in, and Congress must make full disclosure mandatory. The too-cozy ties between doctors and drug makers must end."
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"The legislation requiring public disclosure of the financial relationships between healthcare vendors and physicians has been widely discussed in policy circles for years. Critics claimed payments for speaking, consulting, research or even the small trinkets and meals delivered during routine sales calls unduly influenced physician choices and inflated healthcare costs. To combat those effects, Congress required public reporting of those payments in a publicly accessible database. The legislation, labeled the Physician Payment Sunshine Act, was included in the 2010 healthcare reform law."
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Prescription project director Danny Carlat identifies issues with the Physician Payments Sunshine Act requiring further clarification and guidance. Addressing those would ensure that manufacturers can appropriately implement the final rule, and enable consumers to benefit from transparency reports published by the Centers for Medicare & Medicaid Services.
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The Pew Charitable Trusts is working to decrease the influence of pharmaceutical marketing on doctors’ practices. With a three-year grant from the Attorney General Consumer and Prescriber Education Grant Program, Pew is collaborating several partners to improve conflict-of-interest policies within the 158 medical schools and 400 major teaching hospitals in the United States.
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The Pew Charitable Trusts appreciates this opportunity to submit comments to CMS's "Information Collection Activities" draft guidance. We suggest that both the research and non-research payment templates be modified in order to make it easier for consumers to identify which drugs, devices, biologicals, or medical supplies are associated with particular transfers of value.
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On Feb. 1, 2013, the Centers for Medicare & Medicaid Services published the final rule guiding implementation of the Physician Payments Sunshine Act, which Congress passed as part of the Affordable Care Act in March 2010 to increase transparency in the relationships between physicians and drug and medical device makers. Here are some of the highlights.
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"The Obama administration issued a new rule this month that requires the makers of prescription drugs and other medical products to disclose what they pay doctors for various purposes, like consulting or speaking on behalf of the manufacturer. This overdue rule adds much-needed weight to previous, more limited disclosure requirements."
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Allan Coukell, director of medical programs for The Pew Charitable Trusts, issued the following statement in response to the Centers for Medicare & Medicaid Services' final rule for implementing the Physician Payments Sunshine Act, which will bring transparency to the financial relationships between physicians and drug and medical device companies.
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In 2011, the pharmaceutical industry spent nearly $29 billion on drug promotion — more than $25 billion on marketing directly to physicians and almost $4 billion on advertising directly to consumers (mainly through television commercials). This multi-pronged approach is designed to promote its products by influencing doctors’ prescribing practices.
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"Harmonizing conflict-of-interest standards will depend on the Centers for Medicare & Medicaid Services moving forward to implement the federal Sunshine law, which is now more than a year behind schedule. Industry, consumers and academic stakeholders are all waiting on CMS to issue a final rule."
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During a session at the American Psychiatric Association's annual meeting on conflicts of interest, experts delved into the link between psychiatry and the pharmaceutical industry. While several speakers at the session pointed out that other specialties are similarly entangled with industry, "everyone does it" is generally not a valid defense where conflicts of interest are concerned.
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Dr. Daniel Carlat, Director of the Pew Prescription Project, appeared before the U.S. Senate Special Committee on Aging to testify about the importance of implementing the Physician Payments Sunshine Act as quickly as possible.
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Pew Prescription Project Director Daniel Carlat opines in the Philadelphia Inquirer: "Monetary relationships among doctors and drug and device companies are not inherently bad; in fact, they are crucial for advancing medical research and patient care. Yet they can also skew prescribing practices and research results. That's why transparency and education are such an elegant solution: They allow these often important relationships to exist, but only on the condition that other professionals and patients are fully informed about them."
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"Every five years, lawmakers, lobbyists, patient groups and agency regulators line up to take their shot at changing how things get done at the Food and Drug Administration."
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The Pew Charitable Trusts “Pew” and Medtronic, Inc. are pleased to jointly comment on the Department of Health and Human Services, Centers for Medicare & Medicaid Services proposed rule implementing Section 6002 of the Affordable Care Act.
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Pew’s main goals in commenting on the proposed rule are to ensure timely implementation and to promote the interest of full transparency by ensuring that data is collected, reported, and published in the most complete, consistent and accurate manner possible.
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