General Health Articles

Hearing To Focus On Direct-To-Consumer Ads For Prescription Drugs

admin — Sat, 10 May 2008 00:00:00 +0000

Officials for Pfizer, Johnson & Johnson, Merck and Schering-Plough on Thursday will testify at a House Energy and Commerce Oversight and Investigations Subcommittee hearing that Democrats hope will “lay the groundwork for future legislation to tighten controls on drug marketing,” the Wall Street Journal reports. According to the Journal, although Democrats last year “lost a fight over proposals to strengthen government regulations” of direct-to-consumer television advertisements for prescription drugs, recent concerns about ads for the cholesterol medications Vytorin and Lipitor and the anemia treatment Procrit have “given Democrats … ammunition for a new battle” (Mundy, Wall Street Journal, 5/8).

The subcommittee will examine whether Merck and Schering-Plough in ads for Vytorin overstated the benefits of the medication, which a study released in January found no more effective than a treatment available in generic form in the prevention of accumulation of plaque on artery walls (AP/Boston Globe, 5/8). In addition, the subcommittee will examine the decision by Pfizer to feature Robert Jarvik, the inventor of the first artificial heart, in ads for Lipitor. The subcommittee earlier this year raised concerns that the ads could mislead the public because they portray Jarvik, who is not a licensed cardiologist, as a medical expert. The subcommittee also will examine the decision by J&J and subsidiary Ortho Biotech to continue to air ads that promoted Procrit as a treatment for fatigue — a use for which FDA has not approved the medication — despite repeated requests by the agency to revise the ads (Wall Street Journal, 5/8).

Witnesses from the American Medical Association, the Kaiser Family Foundation and other groups also will testify at the hearing (AP/Boston Globe, 5/8).

Comments
Subcommittee Chair Bart Stupak (D-Mich.) said, the “The issues with these ads aren’t limited to the three campaigns we will examine in our hearing,” adding, “But they serve as excellent case studies for problems prevalent in DTC marketing” (Loewenberg, The Politico, 5/7). According to Stupak, the hearing could lead to legislation to allow FDA to require revisions to DTC TV ads for prescription drugs before they air (Wall Street Journal, 5/8).

AMA President-Elect Nancy Nielsen, who will testify at the hearing, said that the group seeks increased regulations on such ads, with large penalties for violations. She added, “We have to recognize that direct-to-consumer adverting is primarily marketing, not education.”

Such ads lead “people toward the newest and very often the most expensive treatment options,” Drew Nannis, a spokesperson for AARP, which plans to submit testimony for the hearing, said.

Steven Findlay — a health care analyst for Consumers Union, which supports a moratorium on such ads for two years after prescription drugs reach the market — said, “DTC ads do promote a pill culture in this country. They foster a culture in which we think there is a pill for every ill” (The Politico, 5/7).

However, Pharmaceutical Research and Manufacturers Association Vice President Ken Johnson said such ads prompt patients to visit physicians and help “start important doctor-patient discussions about conditions that might otherwise go undiagnosed or untreated” (Wall Street Journal, 5/8).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Prescription Drug Ads Need More Oversight To Protect Patients

admin — Fri, 09 May 2008 20:00:00 +0000

The American Medical Association (AMA) called for better government oversight of prescription drug advertisements directed at consumers to protect patients from misleading information. AMA President-elect Nancy Nielsen, MD, shared the AMA’s concerns with some direct-to-consumer advertisements (DTCA) in testimony to the House Energy and Commerce Committee Subcommittee on Oversight and Investigations.

“Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug’s benefits than risks,” said Dr. Nielsen. “Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs.”

At the hearing, the AMA discussed the need for FDA regulation over DTCA and shared guidelines for DTCA that address advertising content, disclosures, and audiences targeted.

“The AMA guidelines for DTCA can help ensure that patients receive information about prescription drugs that is accurate, educational, well-balanced and encourages patient-physician communication,” said Dr. Nielsen. “We look forward to working with Congress to achieve our shared goal - that direct-to-consumer advertisements focus on truly helping patients rather than maximizing pharmaceutical companies’ bottom line.”

American Medical Association

Senate Version Of Supplemental War Appropriations Bill Would Delay Medicaid Regulations, Increase FDA Funds

admin — Fri, 09 May 2008 19:00:00 +0000

The Senate Appropriations Committee on Thursday plans to mark up a supplemental war appropriations bill that will include language to block for one year seven new Medicaid regulations proposed by the Bush administration, as well as additional funds for FDA, CQ Today reports (Higa, CQ Today, 5/7). The House version of the legislation, which would cost more than $183 billion, includes the Medicaid language but not the FDA funds (Scully/Bourge, CongressDaily, 5/8).

According to Sen. Herb Kohl (D-Wis.), chair of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, the Senate version of the bill will include $275 million for FDA. The legislation would provide $125 million for food safety; $100 million for medication and medical device safety; $40 million to modernize FDA science and the agency work force; and $10 million to upgrade FDA facilities and laboratories. Kohl said, “With serious concerns about the FDA lacking the resources to do its job, this much needed increase in funding means the agency can hire more food inspectors, open offices overseas, expand data collection and take other necessary steps to prevent our food and drug safety being severely compromised” (Higa, CQ Today, 5/7).

However, the mark up of the bill might “prove to be nothing more than an exercise in regular appropriations procedure,” as Senate Majority Leader Harry Reid (D-Nev.) “has made it clear that he intends to bring the House bill to the floor” and Republicans likely will oppose the legislation, which “appeared certain to have much more domestic spending than the House bill,” CQ Today reports (Rogin/Clarke, CQ Today, 5/7).

Delay Likely for House Version
Democratic leaders had hoped to move the House version of the bill to the floor on Thursday, but on Wednesday they “expressed pessimism that they would be able to move the bill” this week because of opposition from the Blue Dog Coalition and “Republican procedural delays” on a separate bill, CongressDaily reports (CongressDaily, 5/8).

The Blue Dog Coalition opposes the legislation because of a lack of offsets for some of the funds that the bill would provide. The House Rules Committee late Wednesday “sent out a notice that it did not plan to consider a rule for debate of the supplemental measure until next week — a clear indication that the House leadership’s appeals to the Blue Dogs had failed,” according to CQ Today (Rogin/Clarke, CQ Today, 5/7).

Bush on Wednesday reiterated his promise to veto the legislation in the event that the cost would exceed $108 billion (Lengell, Washington Times, 5/8).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

The Problem With Counterfeit Drugs

admin — Fri, 09 May 2008 18:00:00 +0000

An editorial published this week in The Lancet
calls attention to the growing crisis concerning counterfeit drugs.
Currently, America is dealing with a potential case of counterfeiting
in the drug heparin. It is possible that a contaminant found in batches
of heparin has led to the death of at least 81 patients.

Between 2000 and 2006, according to the Editorial, the US Food and Drug
Administration (FDA) has witnessed an 800% increase in the number of
new counterfeit cases. It is thought that in developing countries, with
weak or non-existing regulatory systems, about 10 - 30% of drugs are
counterfeit. Due to their high demand, antimalarials are a popular
choice for counterfeiters - fake medicines have been introduced into
the markets in several countries in Asia.

The Editorial calls for a multi-lateral approach in order to combat
counterfeiters, and states the necessary involvement of WHO, countries
and the pharmaceutical industry.

“According to WHO, only 20% of its member states have well-developed
drug regulatory systems, and around 30% have no or weak drug
regulation… Drug authorities also need to work effectively with
customs, the police, scientists, health workers, WHO, and INTERPOL.
This type of collaborative approach has proved successful in tackling
counterfeit antimalarials in southeast Asia. The pharmaceutical
industry should be legally required to report suspected cases of
counterfeiting to the relevant national drug authority - a practice which
is currently voluntary. Companies must also be encouraged to lower the
prices of their products in developing countries to reduce the economic
incentive for counterfeiters,” writes the Editorial.

It concludes that, “There is no magic bullet to deal with counterfeit
medicines. Countries need to adopt multipronged, multidisciplinary
approaches to combat the problem. WHO and donor countries should
provide support to developing nations to strengthen their drug
regulatory systems. But individual governmental commitment to this goal
is essential. Without it, public safety will continue to be
compromised.”

Combating counterfeit drugs

Editorial

The Lancet (2008): 371[9624]. p. 1551.

Click
Here to View Journal Website

Written by: Peter M Crosta

Studies Examine Ways To Curb Nonemergency Care In EDs, Risks Of Individual Health Insurance

admin — Fri, 09 May 2008 16:00:00 +0000

“Safety Net Hospital Emergency Departments: Creating Safety Valves for Non-Urgent Care,” Center for Studying Health System Change: According to the brief, hospital emergency departments are treating more patients, including those with non-urgent health needs, and safety net hospitals are looking for ways to meet those non-urgent needs more efficiently. The brief finds that a combination of approaches could help curb ED use for nonurgent care, including expansion of community health centers and community and health clinics, as well as strategies to improve their accessibility. Aligning hours of operation and available services among existing providers also could increase patients’ care options at lower costs, according to the brief (HSC release, 5/7).

“How Risky Is Individual Health Insurance?“ Health Affairs: The study, by Mark Pauly and Robert Lieberthal of the University of Pennsylvania Wharton School, finds that insured people in fair or poor health are less likely to drop or lose coverage entirely if they have individual coverage rather than small-group coverage. It also states that workers with relatively poor health and small-group coverage who became unemployed were considerably more likely to become uninsured than their counterparts with individual coverage. People with either large- or small-group insurance, however, were less likely to become uninsured than those covered through the individual market, the study says (Health Affairs release, 5/6).

“Planning for the Future — Long-Term Care and the 2008 Election,” New England Journal of Medicine: In the perspective, David Stevenson, an assistant professor of health policy at Harvard Medical School, discusses how the “candidates in the 2008 presidential race have been virtually silent about long-term care policy,” despite the fact that long-term care “has all the makings of a great campaign issue.” Stevenson also examines what long-term care issues should be addressed, including financing, system-structure and whether the emphasis should be on public or private programs (Stevenson, NEJM, 5/8).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Contract Dispute Between California Hospital And Insurer Disrupts Care For Hmong Immigrant Children, Parents Say

admin — Fri, 09 May 2008 15:00:00 +0000

A dispute between Children’s Hospital Central California and Anthem Blue Cross has caused Hmong immigrant children enrolled in government health insurance programs in Fresno County, Calif., to face long waits for specialists and to travel to other cities to seek care, dozens of parents testified on Tuesday at a county Board of Supervisor’s meeting, the Fresno Bee reports. The contract between Children’s and Blue Cross ended Aug. 1, when the two parties could not agree on payment levels for children enrolled in Medi-Cal — California’s Medicaid program — and Healthy Families — the state’s version of SCHIP.

Gia Xiong of the Center for New Americans said some parents have been told to take their children to San Francisco to seek care, adding, “The reality is, a newly arrived refugee has no idea where San Francisco is or where the hospital is.” At the meeting, supervisors said Blue Cross is responsible for not providing the children with accessible care. Supervisors directed the county’s health director, Edward Moreno, to begin to develop a list of steps the county could take to ensure the children have access to care. Supervisors also called for a legislative hearing to discuss the contract dispute.

According to the Bee, the county’s ability to resolve the matter is “unclear.” Stan Rosenstein, chief deputy director of the California Department of Health Care Services, said it is the state’s responsibility to address the issue. Julie Hornback, director of the county’s Employment and Temporary Assistance Department, said the county is not involved in confidential negotiations between hospitals and insurers.

Talks between Blue Cross and the hospital are ongoing, the Bee reports. Leslie Porras, a spokesperson for Blue Cross, said that negotiations are “very positive” and that the company is “hopeful that we can reach an agreement here soon” (Anderson, Fresno Bee, 5/6).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

U.S. Supreme Court To Consider Asylum Cases Of Men Whose Partners Were Forced To Undergo Abortions In China

admin — Fri, 09 May 2008 14:00:00 +0000

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

House Energy And Commerce Committee Approves Bill To Reauthorize Community Health Centers Program

admin — Fri, 09 May 2008 12:00:00 +0000

The House Energy and Commerce Committee on Wednesday by voice vote approved a bill (HR 1343) that would reauthorize the federal community health centers program through fiscal year 2012, CQ Today reports (Mattingly [1], CQ Today, 5/7).

The legislation, sponsored by Rep. Gene Green (R-Texas), would authorize more than $14 billion over five years in all 50 states; Washington, D.C.; and U.S. territories. The bill would provide $2.1 billion in FY 2008 and $2.5 billion in FY 2009.

In addition, the legislation would allow limited liability protection for physicians who volunteer at community health centers and extend liability protections to employees who travel to provide emergency care. The bill also would require 30 demonstration grants for integrated health systems that provide access to primary and preventive care (Posner, CongressDaily, 5/8).

Green said, “Health centers represent our nation’s largest primary health care system and serve as a medical home to more than 15 million Americans, the overwhelming majority of whom are low-income or uninsured individuals,” adding, “This bill will double the number of Americans who can be served in these health centers.” The Senate Health, Education, Labor and Pensions Committee in November 2007 approved a similar bill (S 901) (CQ Today, 5/7).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Wichita Falls Entrepreneur Elected TMA Alliance President, USA

admin — Fri, 09 May 2008 11:00:00 +0000

Wichita Falls businessman Patrick Hearn was elected president of the Texas Medical Association Alliance (TMAA). TMAA is the volunteer service organization of TMA physicians and physicians’ spouses. He is married to Yvonne Hearn, MD, a TMA member physician who is a pathologist in Wichita Falls.

Mr. Hearn is the 91st president of the organization. Until now, all TMAA presidents have been female. “It feels odd to be the first male to serve as president of the alliance, but I’m honored to follow in the footsteps of some extraordinary women, who have set the bar high,” Mr. Hearn said. He will serve as president for one year.

He has been active in the TMAA since 2002, including serving as vice president of membership and vice president of future planning. He also was the District 30 chair of the Texas Medical Association Political Action Committee. Mr. Hearn served as president of the Wichita County Medical Society Alliance in 2001-02.

Mr. Hearn graduated magna cum laude with a bachelor of business administration degree from Midwestern State University in Wichita Falls. The Florida native owns and operates a business, Aqua Azul Divers. He and his wife have a daughter, Hillary.

Mr. Hearn looks forward to the upcoming year. “The alliance adds great value to the profession of medicine. I am pleased to align myself with an organization that is a strong political force and attacks Texas’ health care issues head on,” Hearn said.

TMA is the largest state medical society in the nation, representing more than 43,000 physician and medical student members. It is located in Austin and has 120 component county medical societies around the state. Organized in 1853, TMA’s key objective is to improve the health of all Texans.

Texas Medical Association

Statement By Mike Leavitt, Secretary Of Health And Human Services, On Designation Of Thomas Barker As Acting General Counsel

admin — Fri, 09 May 2008 11:00:00 +0000

“I am pleased that the President has designated Tom as this Department’s Acting General Counsel. Tom has served HHS in a variety of capacities for more than seven years and has an extraordinary understanding of our nation’s health care policies and priorities.

“As General Counsel, Tom will lead the cadre of more than 400 attorneys who provide legal services within HHS. His breadth and depth of experience are a valuable asset to this Department. I appreciate Tom’s continued commitment to improving the health of our nation and welcome him to this new role.”

Jim Stansel, currently serving as Acting General Counsel, will move into the position of Counselor to the Secretary for Health Policy.

“Jim has played an integral role in the Office of the General Counsel for the last two years. I thank him for his dedicated service and look forward to welcoming him as my new Counselor for Health Policy.”

http://www.hhs.gov