Original article written by Jeannette Pai-Espinosa, WeNews commentator, and published in the June 23, 2009 issue  of  Women’s eNews and reprinted here with permission. Editor’s Note: The following is a commentary. The opinions expressed are those of the author and not necessarily the views of Women’s Enews.

(WOMENSENEWS)–A June 23 ABC Primetime special called “Family Secrets” did a good job of presenting the issues and challenges of one segment of the teen parent population.

Nearly all the stories shared in the special were of young mothers with family support to help them face the trials and to share in the joys.

For these young parents, an unintended pregnancy was the result of absent, forgotten or malfunctioning birth control in the life of an otherwise “average” or even “model” young adult. Still, even for these teens, we saw in ABC’s special how hard it is for them to make it all work.

For other young parents, however, a birth control failure is the most recent misfortune in a lifetime of poverty, abuse, neglect, addiction and violence. Traumatic experiences have left these young people searching high and low for safety, belonging, love and support. And sometimes, creating a family seems like the only way to get it.

Moreover, in many cases teen pregnancy is a long family tradition. We refer to these young women as young mothers at the margin, because they live at the edge of the American dream, working to break the destructive cycles into which they were born.

There isn’t any meaningful dialogue about addressing the deeply rooted social issues faced by this population.

Largely Invisible

They remain out of sight and largely invisible.

It’s not because they are a rarity.

Each year thousands of young women and men become parents with no support system and no means of providing for their family.

In 2006, there were more than 350,000 unmarried teenage mothers ages 14 to 18 in the United States, and many of them wind up parenting alone.

Meanwhile, funding for services and programs to support them and their children continues to disappear.

California public health officials say proposed budget cuts could hurt or end the state’s Maternal, Child and Adolescent Health Program, which provides care for high-risk women and teenagers during pregnancy and for up to one year after giving birth, according to the Press-Enterprise newspaper in Riverside, Calif.

Focusing significant national energy, work and resources on young mothers at the margin is the right thing to do.

A Solid Investment

It’s also a good investment. Young mothers need the chance to develop new skills and relationships so they can learn how to become good parents who are personally and financially self-sufficient.

If we don’t provide them the support, no one will, and we will never be able to reduce the intergenerational poverty and reliance on public programs.

We know what works: social support, education and good jobs, made possible by high-quality health care, childcare, affordable housing and reliable transportation.

Young mothers and their children have much to offer this country as part of the work force, volunteers and dedicated parents.

We don’t need to look any further than President Obama to see how a young mother with the support of her family can change the world. Imagine a country where all young mothers had the same support.

Jeannette Pai-Espinosa is president of The National Crittenton Foundation, which supports the empowerment of vulnerable girls, young women and their families. For more information, visit http://www.TheNationalCrittentonFoundation.org

Women’s eNews welcomes your comments. E-mail us at editors@womensenews.org . -

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©2009 An Inconvenient Woman. All Rights Reserved.

This week’s Natural News lead with an eye-pop ping headline that asked readers to think about CHEMO differently. I have to admit, I have been thinking about Chemo differently for several years. When Suzanne Summers announced that she was treating her breast cancer “naturally”– the media fire storm could not have been greater if the woman had clubbed baby seals to death while naked on live TV. Her announcement didn’t phase me as much as the medical establishment’s reaction to her statement concerning, what to me was, a personal choice. I’m of the ‘Cher-school of thought’ when it comes to boobs. “They are mine, and if I want to and am willing, and have the ability to pay for it, I can move them to my back if I want to.”  The move to the state decreed ‘Doctatorship’ is troubling. Should the medical profession have the right to dictate, backed up by the court system, a treatment for an individual, be that individual a child or an adult? Personally, I’m still thinking about the whole process of  “Public Health Decrees vs Personal Choice” In the mean time read what the writers at Natural News have to say about this new Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine has to say. Inconvenient Women, read all sides of an issue before making a medical decision.

(NaturalNews) Chemotherapy drugs used in standard cancer treatments are associated with a huge list of side effects, from hair loss and nausea to nerve pain, sexual problems and mouth sores. Now a new study from the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine has identified another side effect caused by a commonly used chemotherapy drug — death.

A startling number of women have died from a severe allergic reaction after being injected with Cremophor-based paclitaxel, a solvent-administered taxane chemotherapy. What makes this extra tragic is that the researchers found some of the dead women had already been treated for early stage breast cancer and could well have been cured — if the chemo prescribed to prevent a theoretical recurrence of cancer in the future had not killed them.

The report, presented at the 45th Annual Meeting of the American Society of Clinical Oncology held recently in Orlando, Florida, found there were 287 unique cases of hypersensitivity reactions submitted to the FDA’s Adverse Event Report System between 1997 and 2007 in patients who received the solvent-laced chemo drug. Of these, an alarming 38 percent, 109, died. Because adverse event reports usually only document from one to 10 percent of the actual incidence of serious side effects, the number of hypersensitivity reactions as well as deaths is probably much greater.

The severe allergic reactions are believed to be caused by the chemical solvent used to dissolve some chemo drugs before they can be injected into the blood stream. Two of the women who died from an allergic reaction had early-stage breast cancer, which had already been surgically removed. They were being subjected to the Cremophor-containing paclitaxel to supposedly keep the cancer from returning.

Although both of these patients were given additional drugs before the chemotherapy to reduce the risk of hypersensitivity reactions, they still died. In fact, RADAR researchers found that 22 percent of all the deaths from the chemo drug occurred in patients who had been pre-treated with medications to prevent hypersensitivity reactions. Another 15 percent of these chemo patients experienced life-threatening respiratory arrest.

“The deaths of women with early-stage breast cancer are particularly disturbing because without the adverse reaction, they could have likely had 40 years of life ahead of them,” study leader Charles Bennett, M.D., RADAR program coordinator and a professor of hematology/oncology at Northwestern’s Feinberg School, stated in a media release.

“Patients receiving Cremophor-based paclitaxel should be given medications to prevent hypersensitivity reactions, but what is sobering, as the study has shown and as the black-box warning indicates, women suffer anaphylaxis despite receiving steroid premedication,” he added. “Physicians may also want to consider exploring other alternative chemotherapy options that do not include Cremophor.”

Cremophor-containing paclitaxel has been associated with a wide range of hypersensitivity reactions, ranging from mild skin irritations to cardiac collapse. “The results of our review suggest that physicians should be vigilant in monitoring the safety of their patients undergoing chemotherapy treatment,” said Dr. Bennett, who also is the A.C. Buehler Professor in Economics and Aging at the Feinberg School and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

For more information:
http://www.cancer.gov/cancertopics/…
http://www.oncolink.com/treatment/a…

©2009 An Inconvenient Woman. All Rights Reserved.

During
this public health emergency, the FDA has issued Emergency Use
Authorizations that expand access to medical products that may become
necessary.

Two antiviral treatments covered by Emergency Use Authorizations,
Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included
in many emergency stockpiles.

All companies, U.S. states and localities, and other organizations
with Tamiflu and Relenza that are approaching, or past, the labeled
expiration date, are urged to consider keeping it while the U.S.
Department of Health and Human Services evaluates options, including
those that may allow for their use if needed during this 2009 H1N1 flu
virus outbreak.

If the stockpiling entity decides to retain expired or
soon-to-expire Tamiflu and Relenza, it should be maintained and
monitored under the product’s labeled storage conditions.

These organizations are also urged to contact the FDA’s Emergency
Operations Center with information on how much Tamiflu and Relenza in
their stockpiles is at or approaching expiration.

This information should be reported to:

FDA’s Emergency Operations Center
301-443-1240.

This statement is not directed to individual patients who already
have these two products in their homes. Individuals with these products
should continue to follow the directions from their doctor, pharmacist
or other health care professional.

©2009 An Inconvenient Woman. All Rights Reserved.

MedWatch Online Voluntary Reporting Form (3500)

Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:

• FDA-regulated drugs,
• biologics (including human cells, tissues, and cellular and tissue-based products)
• medical devices (including in vitro diagnostics)
• special nutritional products and cosmetics

A Message about Privacy

You can continue to make adverse event reports under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting in any way. In fact, the Privacy Rule specifically permits covered entities (such as pharmacists, physicians or hospitals) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.

For more information, please go to the Medwatch HIPAA Compliance page.

What NOT to Report to MedWatch Using Online Form 3500

• Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://secure.vaers.org/VaersDataEntryintro.htm.
• Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
• Mandatory reporting:
  Drugs and Biologics
  Devices

Frequently Asked Questions: submitting your voluntary report online (both versions):

• Will my report be secure when submitted over the internet?
• Can I submit attachments using this online reporting form?
• Are instructions for completing this form available?
• How will I know that this report has been received?
• I don’t want to submit a report now but have a question about a medical product. How can I get my questions answered?
• What browser and technical requirements are needed?
• Will I be able to print or save my report on my computer?

©2009 An Inconvenient Woman. All Rights Reserved.

2009 H1N1 Flu Virus and Antivirals Questions and Answers

Q: Do the FDA’s Emergency Use Authorizations for antiviral drugs (Tamiflu and Relenza) cover their use for both prevention and treatment?
The EUAs for Tamiflu and Relenza cover the emergency use of the drugs, subject to the terms and conditions of the EUAs. Tamiflu and Relenza are also approved by the FDA for treatment and prevention under certain circumstances. Specifically:

Tamiflu is approved:

to treat uncomplicated acute illness due to influenza infections in patients 1 year of age and older who have been symptomatic for no more than 2 days, and
to prevent influenza in patients 1 year and older.

Relenza is approved:

to treat uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than two days, and
to prevent influenza in adults and pediatric patients 5 years of age and older.

The EUA for Tamiflu authorizes, under certain circumstances, Tamiflu to be used to treat and prevent influenza in children under 1 year of age, and provides alternative dosing recommendations for children older than 1 year (based on age instead of weight). (We note that because of limited experience, use of Tamiflu for prevention of 2009 H1N1 flu in infants less than 3 months of age is not routinely recommended but may be considered if the need is considered critical.) The EUA also authorizes distribution of Tamiflu deployed from the Strategic National Stockpile and that has had its expiration date extended under the federal government’s Shelf Life Extension Program (SLEP).

The EUA for Tamiflu and Relenza authorize the drugs to be used at later time points (i.e., in patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have “uncomplicated acute illness” per se). The EUAs for Tamiflu and Relenza authorize the drugs to be distributed or dispensed without all of the FDA-required prescription label information. The EUAs for Tamiflu and Relenza authorize the drugs to be accompanied by certain written emergency use information. The EUAs also note that public health officials or other volunteers may distribute Tamiflu and Relenza to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.

Q: Do the Emergency Use Authorizations for the antiviral drug products Relenza and Tamiflu cover only products in the Strategic National Stockpile (SNS) or do they cover the state and local stockpiles and private sector stockpiles?
The EUAs for Relenza and Tamiflu are not limited to Tamiflu and Relenza held in the Strategic National Stockpile. However, the EUAs are limited to Tamiflu and Relenza distributed under the authority of the Centers for Disease Control and Prevention (CDC) and/or the appropriate local state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that private entities are part of state and local emergency response plans for distributing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs. However, private entities simply distributing product outside of the emergency response plans of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals) would not be within the scope of the EUAs.

Q: Do the Emergency Use Authorizations for Tamiflu and Relenza cover regular pharmacy prescriptions?
The EUAs are limited to Tamiflu and Relenza distributed under the authority of the U.S. Centers for Disease Control and Prevention and/or the appropriate state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that pharmacies are part of state and local emergency response plans for distributing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs.

Q: Do the Emergency Use Authorizations for antivirals allow hospitals without outpatient pharmacies to dispense Tamiflu and Relenza?
The EUAs are limited to Tamiflu and Relenza distributed under the authority of the U.S. Centers for Disease Control and Prevention and/or the appropriate state and local public health authorities, and impose conditions on CDC and the state and local public health authorities for doing so. To the extent that hospitals without outpatient pharmacies are part of state and local emergency response plans for dispensing drugs in an emergency in compliance with the terms and conditions contained in the EUAs, they would be covered by the EUAs.

Q: Under the FDA’s Emergency Use Authorizations for Tamiflu and Relenza, what information should be given to a patient?
The Fact Sheet for Patients and Parents authorized under the Tamiflu and Relenza EUAs must be made available to the patient or recipient of the product through appropriate means, which may include distribution of the Fact Sheets with the product.

Q: Under the FDA’s Emergency Use Authorizations for Tamiflu and Relenza, what does it mean to make available medication information “through appropriate means?”
A condition of the EUAs for Tamiflu and Relenza provides that state and/or local health authorities make available “through appropriate means” fact sheets developed for recipients and for health care providers for this emergency use. Making these fact sheets available “through appropriate means” can include (but is not limited to) handing that information to the recipient with the product, or otherwise making it available for reference at the location where medications are being distributed, depending on the circumstances of the emergency.

Q: In the Emergency Use Authorizations for Tamiflu and Relenza, what kind of “additional information,” which is consistent with the fact sheets, can be provided by the CDC and state or local authorities?
Examples of “additional information” include direct translations of the fact sheets into other languages, a poster display, and DVD or television announcements that relay the information contained in the fact sheets.

Q: Why does the Emergency Use Authorization for Tamiflu state that it covers Strategic National Stockpile assets and those authorized under SLEP, but the EUA for Relenza does not make the same statement?
The EUAs for Tamiflu and Relenza cover all Tamiflu and Relenza that is being distributed as part of a government (federal, state or local) emergency response as specified under the EUAs. This can include Tamiflu and Relenza from the Strategic National Stockpile (SNS), but can also include state or local stockpiles of Tamiflu and Relenza, provided it is distributed in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency response plans of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals), subject to the terms and conditions of the EUAs. In addition, it should be noted that while Tamiflu is part of the federal Shelf Life Extension Program (SLEP), Relenza is not. For this reason, reference to SLEP in the Relenza EUA was unnecessary.

Q: Does a physician need a confirmed diagnosis before prescribing Tamiflu?
Tamiflu is approved for both the treatment and prevention of influenza. Health care providers should use their best judgment given the circumstances and extent of exposure when deciding whether prophylaxis and/or treatment is warranted.

Depending on the characteristics of an outbreak, public health officials may provide additional recommendations for prioritization and identification of appropriate recipients. Because testing may require a few days and might have variable accuracy, and the antiviral drugs are most effective when used early in the course of illness, health care providers may choose to begin treatment based on determination of a suspected or probable case. Published CDC recommendations and case definitions should be consulted as appropriate.

Q: Do the Emergency Use Authorizations override state guidelines regarding dispensing and storage of Tamiflu and Relenza in a public health emergency?
Distribution and administration of Tamiflu and Relenza under the EUAs are subject to the terms and conditions of the EUAs. The EUAs require Tamiflu and Relenza to be distributed in accordance with state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction (a term from the Public Readiness and Emergency Preparedness Act declaration for antivirals).

Tamiflu and Relenza should be stored consistent with the manufacturer’s storage instructions in the approved labeling. The EUA includes a waiver of good manufacturing practice requirements with respect to the holding of authorized Tamiflu and Relenza by CDC and other public health authority(ies) for a period of 90 days. If a public health authority believes that improper storage of their Tamiflu and Relenza may have occurred, please contact the FDA.

©2009 An Inconvenient Woman. All Rights Reserved.

The United States Attorney’s Office

District of Massachusetts

FOR IMMEDIATE RELEASE
JUNE 18, 2009
WWW.USDOJ.GOV/USAO/MA

CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV

PHARMACEUTICAL COMPANY MANAGER SENTENCED FOR OFF-LABEL MARKETING

BOSTON, MA - A Branchburg, NJ, woman was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

Acting United States Attorney Michael K. Loucks; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services, Office of Inspector General; Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service; Kim A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations - Northeast Field Office; and Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.

At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the Government’s evidence would have proven, the following:

From approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, HOLLOWAY trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose. HOLLOWAY also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, HOLLOWAY encouraged her staff to make false safety claims about Bextra in order to sell the drug.

Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the United States FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Bextra was withdrawn from the market in April 2005.

The case was investigated by the Federal Bureau of Investigation, the Office of Inspector General for the Department of Health and Human Services, Special Prosecutions Staff for the U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.

©2009 An Inconvenient Woman. All Rights Reserved.

©2009 An Inconvenient Woman. All Rights Reserved.

The Institute of Medicine has issued  a “scolding,” “stinging,” and “damning” report about financial conflicts of interest in American medicine involving pharmaceutical, medical device, and biotechnology companies.

If enacted, the IOM recommendations will essentially sever the financial ties that bind American medicine–its practitioners, researchers, academic institutions, journals, professional association and so-called “advocacy groups” from industries that have derailed American medicine from its humanitarian public mission.

Dr. David Rothman, whose Institute on Medicine as a Profession at Columbia University (which is bankrolled by financier George Soros) is quoted saying:
“With the I.O.M.’s endorsement, issues that were once controversial now are indisputable; conflicts of interest in medicine are no longer acceptable.”

Most important, the IOM report calls upon Congress to pass legislation that would require drug and device makers to publicly disclose all payments made to doctors–thereby lending important support for the Physician’s Payment Sunshine Act, sponsored by Senators Charles E. Grassley, and Herb Kohl who head the Senate Finance Committee that would do just that.

The IOM report acknowledges that:

“financial ties between medicine and industry may create conflicts of interest. Such conflicts present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine. Recent news stories have documented troubling interactions between industry and physicians, researchers, and medical institutions.”

Though not identified, many of those news stories laid bare gross and pervasive financial conflicts of interest by psychiatry’s leadership, its professional associations, diagnostic and therapeutic practice guidelines, and the academic institutions they are affiliated with–all have been shown to be tainted by industry’s tentacles.  In no other field of medicine have doctors sworn to “do no harm” knowingly prescribed toxic drugs that carry warning labels about induce suicide, metabolic syndrome, diabetes, and cardiac death.

Recently, Gabriel Myers, a seven-year old boy committed suicide.  The child was treated by a “board certified” child psychiatrist in Florida who prescribed four psychotropic drugs for the boy including: the antidepressant, Lexapro, the antipsychotic, Zyprexa, and Eli Lilly’s deadly combination Symbiax (Zyprexa and Prozac). These three drugs were not approved for use in children though they are recommended by the most influential industry-paid child psychiatrists–all carry Black Box warnings which the treating psychiatrist ignored.

Clearly, the IOM committee–including the deans of Emory University and Stanford University who served as external reviewers of the draft report, according to Dr. Bernard Carroll–now recognize that financial relationships with industry are extensive and self-regulation by academic institutions has failed to rein in the most serious conflicts of interest. Indeed, as Dr. Carroll notes on his blog, HealthCareRenewal, both of these deans were confronted with evidence uncovered by the Senate Finance Committee that their institutions’ prominent (now former) chairmen of psychiatry were shown to have multi-million dollar undisclosed financial interests that posed serious conflicts of interest  undermining both human subject safety and the integrity of the research findings.

To combat the current state of confusion created by variable conflict of interest policies adopted by various academic institutions, journals and professional societies, the IOM committee recommends a real universal overhaul that would prohibit financial ties between industry and researchers conducting human research; end industry funding for continuing medical education programs (within two years); end industry payments physician practice guidelines:

“Congress should create a national reporting program that requires pharmaceutical, medical device, and biotechnology companies to make public all payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease groups, and providers of continuing medical education. Public reporting will enhance accountability by allowing academic medical centers, medical journals, and others to verify disclosures made to them by faculty members, article authors, and others.”

Research: “as a general rule, that researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. The only exceptions should be if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research.”

Continuing medical education: “a broad-based consensus process to develop a new system for funding high-quality accredited continuing medical education that is free of industry influence….”a new system of funding … should be developed that is free of industry influence.”

Community physicians: “should also follow the restrictions described previously regarding gifts, including meals, from companies; presentations or articles whose content is controlled by industry; meetings with sales representatives; and use of drug samples.”

Clinical practice guidelines: “influence physician practice, quality measures, and insurance coverage decisions. Given this influence, clinical practice guidelines need to be developed with greater transparency and accountability.

“The committee recommends that professional societies and other groups that develop practice guidelines not accept direct industry funding for guideline development and generally exclude individuals with conflicts of interest from the panels that draft the guidelines

“To reduce the risk for bias within the learning environment, academic medical centers and teaching hospitals should prohibit faculty from accepting gifts, making presentations that are controlled by industry, claiming authorship for ghost-written publications, and entering into consulting arrangements that are not governed by written contracts for expert services to be paid for at fair market value.”

The committee also recommends that: “the Department of Health and Human Services develop a research agenda to create a stronger evidence base for future conflict of interest policies. Such research should evaluate the impact of conflict of interest policies, including both desired outcomes and possible unwanted consequences.”

“Decisions about biomedical research, medical education, and patient care directly affect the public’s health. The public needs to be able to trust that physicians’ decisions are not inappropriately influenced by their financial relationships with industry.”

Although the IOM does not have the power to enforce its recommendations, the Institute usually carries great weight within the medical profession and health-care industry.

Sources: IOM. Conflict of Interest in Medical Research, Education, and Practice
REPORT BRIEF • APRIL 2009  http://www.iom.edu/Object.File/Master/65/981/COI report brief for web.pdf

See also, Peeling the onion: Is more conflict of interest disclosure getting us closer to the truth?
April 24, 2009 | Shelley Wood, The Heart.org WebMD:

©2009 An Inconvenient Woman. All Rights Reserved.

As I read Tracy Staton ’s Fierce Pharma report about Big Pharma’s  $80BILLION pledge, that was the first question that came to mind. Apparently wanting to give the Health Care Reform a boost, Drugmakers have agreed to foot the bill for $80 billion in Medicare drugs over the next decade. Some portion of that will benefit Medicare recipients, who, as you know, are on the hook for several thousand dollars’ worth of meds annually during the “donut hole” coverage gap. Some other portion will lower the cost of health reform, probably via bigger rebates to Medicare.

For thise of us who have not got our heads around the REALLY BIG BUDGET NUMBERS Washington is throwing around these days, $80 billion is less than one-tenth the projected cost of healthcare reform. But by striking this cost-sharing deal with one of the reform effort’s leaders–Sen. Max Baucus–and the White House, drugmakers could shame other providers into cutting their prices, too. Lawmakers will be able to twist some healthcare arms more forcefully, now that pharma has made this deal. And by delivering real, live cost-cutting, the reformers will be able to neutralize critics’ most tangible beef: That reform costs too much.

AARP is set to endorse the deal today at the White House, along with the President, who’s already praised the agreement and called it a “turning point” in reform efforts. PhRMA was quick to pat itself (and the industry) on the back for the savings: “America’s pharmaceutical research and biotechnology companies are signaling their strong support for these critically important efforts,” CEO Billy Tauzin said in a statement. This is a once-in-a-lifetime opportunity and, working together, we can make this hope for a better tomorrow a reality today.” Whether this deal will help drugmakers avoid greater revenue losses to healthcare reform remains to be seen. The full PhRMA press release is posted below.

Pharmaceutical Research and Manufacturers of America (PhRMA)Statement on Medicare Part D Coverage Gap

WASHINGTON, June 20 /PRNewswire-USNewswire/ — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin and PhRMA Board Chairman David Brennan, Chief Executive Officer, AstraZeneca, issued the following statement regarding today’s commitment, as part of health care reform, to help close the coverage gap in the Medicare prescription drug program (Part D):

“PhRMA is committed to working with the Administration and Congress to help enact comprehensive health care reform this year. We share a common goal: every American should have access to affordable, high-quality health care coverage and services.

“As part of that reform, one thing that we have agreed to do is support legislation that will help seniors affected by the coverage gap in the Medicare prescription drug benefit. Although the program has been a tremendous success for the vast majority of seniors, the coverage gap has posed a challenge to some seniors and our companies have been exploring ways to address this issue for several years.

“Under this proposed new legislative program - which represents the first important step in health care reform - America’s pharmaceutical research and biotechnology companies have agreed to help close the gap in coverage. Specifically, companies will provide a 50 percent discount to most beneficiaries on brand-name medicines covered by a patient’s Part D plan when purchased in the coverage gap.

“In addition, the entire negotiated price of the Part D covered medicine purchased in the coverage gap would count toward the beneficiary’s out-of-pocket costs, thus lowering their total out-of-pocket spending. Importantly, the proposal would not require any additional paperwork on the part of the beneficiary nor would an asset test be used for eligibility.

“Since its inception, strong competition among drug plans participating in the Medicare drug benefit has led to significant savings for seniors. On average, beneficiaries are saving $1,200 annually on their medicines, and the average low-income beneficiary saves $3,900, according to the Centers for Medicare and Medicaid Services. This agreement will help to provide additional savings to even more seniors across the nation.

“Even though Medicare beneficiaries are satisfied with their prescription drug coverage - as evidenced by a recent Medicare Today survey showing overall satisfaction has grown from 78 percent at the start of the program in 2006 to 84 percent in 2009 - we have constantly explored ways to improve the benefit.

“This commitment to support legislation that will help close the coverage gap reflects our ongoing work with Congress and the Administrationto make comprehensive health care reform a reality this year.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

©2009 An Inconvenient Woman. All Rights Reserved.

The Germans call it Schweinegrippe, the French talk about la Grippe A. The World Health Organization now calls it “influenza A(H1N1),” and so do government officials in many countries, but not the Dutch, who are sticking with “Mexican Flu.” The Mexican ministry of health, meanwhile, often calls it simply la epidemia.

Martin Enserink of the Science Insider recounts how political correctness is effecting the ever evolving nomenclature of the influenza virus. A few months after the world woke up to the threat of an influenza pandemic, a Babylonian confusion has arisen about what the virus—and the pandemic, if it happens—should be called. And some virologists say WHO’s new name, A(H1N1) may be politically correct but isn’t very clear and is not going to stick.

The U.S. team that first officially reported two cases of the new virus on 21 April called it “swine influenza A (H1N1)” simply because its genes matched those of viruses previously found in pigs. WHO adopted that name as well; during a 27 April teleconference with reporters, WHO influenza expert Keiji Fukuda used the words “swine flu” 22 times, and when asked the next day by a German reporter whether that name was appropriate, Fukuda said “the virus that is identified is a swine influenza virus,” and “we do not have any plans to try to introduce any new names for this disease.”

In the Morbidity and Mortality Weekly Report, researchers from the U.S. Centers for Disease Control and Prevention came up with several creative alternatives, including, on 29 April, “swine-origin influenza A (H1N1) virus,” S-OIV for short. The same name also appears in a paper that was published online May 7, 2009 by The New England Journal of Medicine. But in the 6 May issue of MMWR, CDC coined the name “novel influenza A (H1N1) virus,” this time without an acronym. “It’s clearly a name that is evolving fast,” says Derek Smith, who studies flu virus evolution at the University of Cambridge in the United Kingdom.

WHO’s new name resembles the strict conventions used to distinguish individual virus isolates in the scientific literature. In that system, A/duck/Vietnam/43/2007 (H5N1) is the 43rd A(H5N1) virus isolated in Vietnam in 2007, and it came from a duck. (The species name is sometimes left out for human isolates.) But A(H1N1) alone makes less sense, says virologist Albert Osterhaus of Erasmus Medical Center in Rotterdam, the Netherlands. One of the three subtypes that make up seasonal influenza every year is also an A(H1N1), and so is the virus that caused the 1918–19 pandemic, widely known as the “Spanish flu.” “It’s unfortunate, because it creates confusion,” says Smith.

Nobody is in charge of naming pandemics either. The “Spanish flu” didn’t originate in Spain; it got its name because that country, not involved in World War I, didn’t keep reports about the disease out of the press, thus creating the mistaken impression that it was very hard hit. The 1957–58 pandemic, first seen in China and caused by an H2N2 strain, came to be popularly known as the “Asian flu.” The pandemic of 1968–69, an H3N2 strain, went down in history as the “Hong Kong flu,” because that’s where the first known outbreak occurred.

Calling the new outbreak the “Mexican flu” fits nicely with that tradition, says Osterhaus, who believes that it will be the popular name for the pandemic no matter what public health officials say. That’s also why the Dutch Outbreak Management team, an expert group of which he is a member, continues using the term “Mexican flu,” as does the Dutch government. (Their insistence has triggered a fiery letter from the Mexican embassy in The Hague.) Thompson says there’s “ongoing discussions” at WHO about other potential names. Ideas abound: Some have suggested talking about the “North American flu” in an effort to continue the geographic tradition without singling out any country.

Jon Cohen of the Science Insider has compiled  this chronology of the H1N1 pandemic. This record will updated regularly as news breaks and past events come to light. This information and all hyperlinks have been provided by the Science Insider. If you use or refer to any if this information in your own research, please cite the Science Insider and include track back links. The Science Insider is a great publication and deserves our respect and support.

Influenza A Virus H1N1 Strain, Swine Flu Outbreak - Day by Day

©2009 An Inconvenient Woman. All Rights Reserved.