Chemotalk Newsletter

Chemotalk Newsletter, Vol. 39: July 1, 2011

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O-Kay!  I'm starting July with a piece that illuminates the objections I, and many others, have to the manner in the Komen organization does business:

HOW SUSAN G. KOMEN FOR THE CURE AFFECTS OTHER CANCER NON-PROFITS

by Gayle A. Sulik, PhD

In response to increased publicity surrounding Susan G. Komen for the Cure's questionable trademark and marketing activities, the organization published an official statement on its website, titled: ³Susan G. Komen for the Cure® Sees Trademark Protection as Responsible Stewardship of Donor Funds.²

According to the statement, Susan G. Komen for the Cure® has never sued other charities or put other non-profits out of business, and the organization does not have plans to do so in the future.

Apparently knitters, sandwich makers, and kite fliers who want to raise money for breast cancer or other causes should breathe easier now! Of course, there are many ways to squeeze out organizations, large and small, and Komen's high profile, clout, and overflowing coffers work in conjunction with legal teams, cease and desist orders, and polite suggestions to encourage a political and economic climate in which only the wealthiest survive.

When the National Alliance of Breast Cancer Organizations (NABCO) closed its doors after 18 years of operation, it was because the organization did not want to give priority to fundraising over program delivery. The network of almost 400 organizations, which included advocates, institutions, and healthcare providers, provided labor-intensive programs such as referral and case management that did not have the same allure as the publicity-driven fundraising campaigns that are so appealing to sponsors. Ironically, Komen founder Nancy Brinker was also a founding member of NABCO, along with journalist Rose Kushner who also helped to establish the National Women's Health Network, Diane Blum of Cancer Care, and Ruth Spear who was a patient and author living in New York. When NABCO closed, Komen was one of 12 nonprofit cancer and health organizations to receive non-exclusive rights to NABCO's educational materials at no cost.

This is not to suggest that Komen played a direct role in the closing of NABCO, or that NABCO should have acted differently. The point is that decision upon decision, action upon action, organizations shape the climate in which other organizations operate. NABCO refused to perpetuate itself by catering to fundraising interests at the same time that Komen was ramping up its cause-marketing and corporate partnerships. Three years later, Komen solidified its brand with a name change and new logo, and in the current year the organization has garnered more corporate partnerships than ever. The financial incentives have taken on a life of their own. If they hadn't, we wouldn't be quibbling over trademarks and pink buckets of fried chicken.

Komen's reputation in some circles, especially among key stakeholders in business and medicine, appears to be beyond reproach. But reputations involve more than financial portfolios, and Komen's domineering actions against other charities (whether they move forward to an official legal objection or not) demand a solid explanation.

The public didn't get one. But Komen's official statement did make some clarifications, such as the number of legal oppositions and objections filed against other entities since its founding, the total amount for legal expenses reported in the most recent financial statement, and the total funds invested in programs in the last fiscal year:

Legal oppositions against other charities through the patent and trademark process: 16

Objections filed against companies or for-profit groups: 31 Total legal expenses last year: $515,405

Program budget for the 2010 fiscal year for research, screening and treatment programs, education and advocacy: $283 million.

The statement does not indicate how many cease and desist letters have been delivered to non-profits and charitable organizations since the inception of the organization for trademark reasons, or how many of these occurred after Komen's name change in 2007. Nor does it reveal how much legal work was done on a pro bono basis to offset legal expenses. Aside from providing a few clarifications, Komen's official statement about responsible stewardship of donor funds is misleading. It does not adequately explain why the organization would engage in any activities that would undermine the ability of other charitable organizations to do their own work toward the betterment of public health and the eradication of disease.

Other Komen statements suggest that trademark policing is meant to ensure that there is no confusion about who donor money supports. Susan G. Komen for the Cure with its stylized running ribbon is specific and clear. Kites for the cure without Komen's logo is something else. Where's the confusion? Or maybe that's the point. There is no confusion. If the running ribbon sparkly pin in the Komen shop serves a different function than the generic pink ribbon that I wear on my lapel, then it represents Komen the organization and not the greater cause of breast cancer.

What is certain is that if there were truly a legal battle to be had against any entity over the trademarked Œfor the cure language, Komen has the resources to move it forward. But if it did, the organization could risk its not-for-profit status on its own branded items. In fact, the Komen store could be subject to the same income tax as anything else. What is really at stake here? It's about money.

In the fundraising endeavor, Komen has redefined cure to mean a whole range of activities that do not involve the eradication of breast cancer. In this capacity Komen justifies spending roughly 25 percent of its program budget on research; encourages donors and patrons to light buildings, bridges, pyramids, and statues in pink when these monies could be spent on research; forms partnerships with corporations, some of whose products play a role in the development of chronic illnesses, such as cancer; and attempts to solidify its place as the self-proclaimed leader of a disparate and nonconsensual breast cancer movement.

Yes, Komen parcels out money to some breast cancer organizations, supports some quality research projects, and gives some supporters a platform to come together. But, it also fails to attend to the perspectives and goals of the total breast cancer movement and refuses to answer to a concerned public that only wants to see an end to the breast cancer epidemic. Yet, Komen's official statement maintains that:

"Our reputation for transparency, funding life-saving research and our total dedication to ending breast cancer is unquestioned."

This official statement does not suggest transparency. Clearly, Komen's reputation is being questioned. Instead of recognizing this, Komen ends with a patronizing tug on the heartstrings aimed at destabilizing the critique put forth by those who are concerned as much about breast cancer as Komen purports to be:

"We are disappointed that our supporters have been misled and have been distracted by this issue, especially when many Americans cannot afford the treatment they need, access to breast cancer care is at risk and so many people continue to lose loved ones. Our singular objective is and has always been to find and ensure access to the cures for breast cancer, and we are enormously grateful for those who stand with us in this mission."

No doubt Komen is disappointed. My colleagues and I are disappointed. Women whose mammograms didn't see their tumors are disappointed.* Those who are being treated for pre-cancers as if they were invasive disease are disappointed. My friends with recurrences and metastatic breast cancer are really disappointed. But disappointment means nothing unless it leads to clarity and action.

Komen is right about one thing. This is a critical time when many Americans cannot afford treatment, need care, and continue to lose loved ones. That is precisely why the leaders of advocacy need to think deeply about what they are doing, and how they are doing it. It is why we all need to think about what is lost when fundraising and self-perpetuation become the top priority.

Gayle A. Sulik is a medical sociologist and author of Pink Ribbon Blues: How Breast Cancer Culture Undermines Women's Health. This post originally appeared in the Oxford University Press blog.

(* That would be me -- and every single one of the women I met during my treatment, who also had dense {lumpy} breasts.)

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DRUG SHORTAGES LEAVE CANCER PATIENTS AT RISK

 By Jane E. Allen, ABC News Medical Unit

A shortage of paclitaxel (Taxol), a CHEMOTHERAPY workhorse for OVARIAN, BREAST, LUNG, and COLON CANCERS, demonstrates once again how vulnerable U.S. hospitals and clinics are to an increasingly unreliable pharmaceutical supply chain, leaving patients at risk.

Last month, paclitaxel joined 196 other drugs on a shortage list compiled by the American Society of Health-System Pharmacists in Bethesda, Md.

Although no one has been able to quantify the number of lives jeopardized by the shortages, the lengthy list underscores that the country is in the midst of a "public health crisis of drugs overall," said Cynthia Reilly, director of the group's practice development division.

Paclitaxel made the list May 13, with a June 16 update. Additions in the last month include such chemotherapy mainstays as doxorubicin, daunorubicin, carboplatin, vincristine and cytarabine, as well as the quick-acting anesthetic propofol, the injectable painkiller Fentanyl, and injectable forms of several powerful antibiotics: clindamycin, ciprofloxacin and gentamicin.

Premier Healthcare Alliance, a performance improvement alliance of more than 2,500 hospitals, put the number of drugs that are in short supply or not available at all even higher -- at 240, with some 400 generics back-ordered for more than five days.

For more than a year, "we've been having a crescendoing of drugs that are in short supply," said Michael P. Link, MD, a Stanford University pediatric oncologist who serves as president of the American Society of Clinical Oncology. He called the paclitaxel crunch "another add-on."

Although some drug shortages can be eased with simple substitutions, regimens that use paclitaxel often lack equally effective substitutes. "That's what makes not just this, but all of the chemotherapy shortages significant," Reilly said. "There are cancer patients who will die because of this. This could change their survival."

Some of the shortages have been making it harder to treat certain malignancies, Link said. "Without cytarabine and daunorubicin, you cannot treat leukemia," he said.

At Stanford's Lucile Packard Children's Hospital, where he practices, the daunorubicin shortage means "we are at risk for having to triage our patients, which patients we'll be able to give the drugs to. We're hoping to get more so we don't face that awful crisis. Other practices have."

Shelly Burgess, an FDA spokesperson, said the paclitaxel shortage was "not a complete national outage" because most of the five generic manufacturers still had some of the drug on hand. Bedford Laboratories of Bedford, Ohio, had paclitaxel on back-order and "plans to have supplies available again by the end of the month," she said.

Bedford, which has 20% of the market for three doses of the drug, expects to release paclitaxel vials to the marketplace soon, said spokesman Jason Kurtz. The company's backlog increased the pressure on the other manufacturers to expedite production.

Teva Pharmaceuticals USA, based in North Wales, Pa., anticipates "some constraint through the summer," said spokeswoman Denise Bradley.

Dan Rosenberg, a spokesman for Hospira of Lake Forest, Ill., said he didn't "have a time frame" for when Hospira could deliver more medication, but that the company was working to help fill the supply gap.

Debra Lynn Ross, a spokeswoman for APP Pharmaceuticals of Schaumburg, Ill., did not provide an immediate response to questions about the shortage.

Shortages Disproportionately Affect Smaller Hospitals

Stanford's Link described the shortages of paclitaxel as geographically variable and partly dependent on the size and clout of institutions. "Large institutions have multiple suppliers, multiple distributors to work with," he said. "They're likely to have more leverage and more options in terms of getting in a supply of drugs."

But most adult cancer patients in the U.S. are treated in smaller practices in their communities, he said, which "tend to operate more on an order-as-needed basis." With less leverage and fewer alternate suppliers, Link said, "they're really getting killed."

The American Society of Clinical Oncology has been collecting anecdotes to get a feel for some of the impact. "We've heard horror stories where patients have actually gone to another state to get their own supply of the drug," he said.

In response to an ABC News request for comment about their paclitaxel supplies, a dozen major U.S. hospitals and medical centers said they hadn't experienced a shortage.  Still, some of the largest and most renowned U.S. medical centers reported being short of paclitaxel, along with other important drugs.

"In my 25 years as a cancer physician, I have never, never seen this," said Jay Brooks, MD, chairman of hematology-oncology at the Ochsner Clinic Foundation and Hospital in New Orleans, where more than 800 doctors -- 20 of them oncologists -- "work together to shift drugs where needed for patients."

At the University of Medicine and Dentistry of New Jersey, where paclitaxel is "our No. 1 drug," some of it has been stashed away "and we are continually ordering from various sources to try to maintain a continual supply," said Lillian Pliner, MD, acting director of hematology/oncology. If the drug becomes unavailable, "we would have to look at alternate treatment protocols."

Roy B. Jones, MD, professor of medicine at the MD Anderson Cancer Center in Houston, called the shortage "manageable but worrisome," and said his medical center was handling it "with fingers crossed." He said he was aware of "many" chemotherapy drugs in short supply, including four at critically low levels and another 20 that he considered "worrisome."

Beaumont Hospital in Royal Oak, Mich., is paying 3.5 times its usual contract cost for paclitaxel to make sure patient care isn't interrupted, Annette Karageanes, assistant director of its pharmacy supply chain, said Thursday. Paclitaxel was "one of 40 products that we evaluated this morning during our drug shortage meeting," she said.

Some Big Medical Centers Managing for Now

Three other large, academic medical centers reported being aware of the paclitaxel shortage but managing to mitigate any effect on cancer patients. Julian Schink, MD, chief of gynecologic oncology at Northwestern University in Chicago, where ovarian cancer patients receive paclitaxel plus either carboplatin or cisplatin, said his pharmacy "proactively identified this issue and stocked up" on Teva's paclitaxel.

James Speyer, MD, medical director of the NYU Clinical Cancer Center, said NYU worked with several suppliers "so that we have not had to delay treatment of patients."

And pharmacist Anita A. Garcia, interim director of investigational drugs at the Cancer Therapy and Research Center at the University of Texas Health Sciences Center in San Antonio, said the center's distributors "are rationing the use of the drug."

Burgeoning drug shortages in the past decade, particularly among injectable generics, suggest that the U.S. pharmaceutical business is operating under "an economic model that apparently is no longer tenable," said Neal J. Meropol, MD, chief of hematology and oncology at University Hospitals Case Medical Center in Cleveland.

He suggested the system might need to change if producers cannot make adequate profits on low-cost generic drugs "to make it worthwhile to continue producing them with a high degree of reliability."

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CANCER DRUGS ON A FASTER TRACK IN U.S.

New cancer drugs are approved in just six months on average in the United States, half the time it takes for the same drugs to be approved in Europe, a new report finds.

The analysis, published by the journal Health Affairs, appears to refute critics who have charged the Food and Drug Administration is less efficient than the European Medicines Agency and has been slower to approve new CANCER drugs.

The study's authors compiled a list of 35 new cancer drugs approved by either of the agencies between 2003 and 2010.  They found that the F.D.A. had approved 32 of the products in an average of 182 days from the time that the first applications were filed.

Only three products took more than a year to receive approval.

By contrast, the European Medicines Agency approved only 26 of the drugs, taking just under a year on average.  Nine drugs were not approved.

All of the drugs that were approved by both agencies were available to patients in the United States first.

The results surprised the study's authors.  "When we realized we were correct, we thought, 'No one is going to believe us because this goes against urban legend,'" said Ellen V. Sigal, chair and founder of Friends of Cancer Research.

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 TRANSPLANT MAY EASE THE PAIN OF CANCER

By Roni Caryn Rabin

Top plastic surgeons from around the country et in Manhattan recently to observe an experimental surgery that may cure lymphedema, a serious complication of BREAST CANCER treatment.

As some surgeons crowded into an operating room at New York Eye and Ear Infirmary and others watched a live video broadcast, Dr. Corinne Becker, the French doctor who pioneered the procedure, harvested lymph nodes from a patient's groin to transplant to her underarm, where nodes had been removed earlier during cancer treatment.

"Viola!" she explained, motioning to her colleagues as she rubbed a small piece of tissue between thumb and fingertips to check for the presence of the small, pearl-shaped lymph nodes.  "Look what is here -- a wonderful node."

She warned that extracting too much tissue could injure the patient, even causing lymphedema in another lim.  Using the French word for 'greedy', she said, "It's better not to be 'gourmand' -- aggressive."

This innovative procedure, called an autologous vascularized lymph node transfer, is used to treat lymphedema, a common side effect of breast cancer treatment.  Removal of the lymph nodes under the arm closest to the affected breast is believed to stem the spread of cancer, although new research suggests it can be avoided in many cases.  But the loss of lymph nodes often leads to chronic swelling and soreness in the arm.

In the new experimental surgery, the missing lymph nodes are replaced with a handful of healthy nodes transplanted from elsewhere in the patient. If all goes according to plan, the lymph nodes make themselves at home in their new location and connect with lymph vessels and start doing their job, filtering waste and draining fluid that has accumulated in the arm.

But the operation is controversial and not without risk, and though it is reported to have cured some patients and improved the condition in many others, it is seldom performed in the United States.  Even proponents say it should be reserved for patients who don't respond to conventional treatment.

The first randomized clinical trial of its effectiveness is just getting underway, led by Dr. Constance Chen, a New York City plastic surgeon who specializes in muscle-sparing reconstructive breast surgery that uses the patient's own tissue

Even in the absence of good data, however, demand for the procedure is bound to grow.  More than 2 million women in the United States have been treated for breast cancer, and some studies suggest lymphedema develops within five years in up to 40% of women who have undergone breast cancer surgery.  While the condition can be managed with constant care and physical therapy, it often severely restricts activity and is generally considered incurable.

In the absence of better data about the benefits of lymph node transfer, however, insurers may balk at covering the procedure, which involves expensive, complex microvascular surgery to connect tiny blood vessels.

"From just a plumbing standpoint, it makes sense -- someone took out the lymph nodes, you put them in," said Dr. Babak Mehrara, a reconstructive plastic surgeon at Memorial Sloan-Kettering Hospital in Manhattan.  "The problem is that some of the science doesn't support it.  It probably works for some people and doesn't for others."

Prior to transferring nodes to their new location, Dr. Becker aggressively clears away dense scar tissue under the arm that may be "clogging up" the lymphatic channels and preventing fluid circulation.  That is one of the riskiest aspects of the surgery, because nerves and blood vessels leading to the arm could be affected.

"We worry that if a person already has a compromised lymphatic surgery, you can go in there and do further damage.  We always say the less surgery the better," said Saskia Thiadens, executive director of the National Lymphedema Network.

But, she added, "Obviously we're eager to see what the outcomes are."

Dr. Chen, who co-organized the symposium hosting Dr Becker with Dr. Joshua L. Levine, director of breast reconstructive services at New York Eye and Ear Infirmary, agrees that more scientific evidence is needed.  But she is optimistic the surgery will benefit patients and says the toll lymphedema takes has not been fully appreciated by the medical community.

"Treatment for lymphedema generally doesn't end," Dr. Chen said.  "Women will say managing their lymphedema is worse than coping with breast cancer -- now they have to deal with an every day affliction that affects their day to day lives."

She is launching the first double-blinded randomized clinical trial of lymph node transfer, a multicenter study that will enroll 88 patients with lymphedema in one arm.  Half will be randomly assigned to lymph node transfer, while others will undergo a dummy surgical procedure.  The patients will be followed for two years after the operation to see if their quality of life improves.

"There are naysayers with every single surgical innovation that comes along," Dr. Chen said.

Dr. Becker claims to have had enormous success, but while she has operated prolifically in Europe and other parts of the world on patients with cancer as well as those with congenital lymphedema, she has published only sporadically.

In a 2006 paper in Annals of Surgery, she reported that 90% of patients improved after surgery and almost half were cured, but the sample included only 24 women and there was no control group.

One of the patients operated on by Dr. Becker and Dr. Chen during the daylong symposium, Jennifer Miller, 40, a portfolio manager at an investment firm in Manhattan, said she has already felt a dramatic improvement.

"I used to have this pain that was like my whole arm had a headache, and that's gone," Ms. Miller said.

Ten days after surgery the swelling in her right arm was reduced by half, compared with measurements taken 10 days prior to the operation, and she has been able to bare her arm, which she used to keep covered in a compression treatment sleeve most of the day.

Though her right arm is still swollen and larger than her left, she said, "It already feels more manageable, and I'm still recovering from surgery.  Even if this is all the improvement I get, I'm happy."

But whether the change is a true effect of the transfer or a placebo effect of undergoing treatment is not known.  Doctors say it is unlikely the transplanted nodes are already functioning, and it's possible some other aspect of the surgery is having a beneficial effect, Dr. Chen suggested.

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I try not to get too political on this site, but it's getting all but impossible to separate treatment from politics:

HOW MEDICAID IS UNDER POLITICAL ATTACK

by Rishi Manchanda, MD, MPH

Mr. M walked into the community clinic where I work with a portable oxygen tank in tow. At 62, he's gaunt and winded, battling a disease that is progressively scarring his lungs. Every breath is a fight. Instead of the clear flow of air, I hear the sound of velcro ripping when I place my stethoscope on his chest. In medicine, his illness is idiopathic, which means the cause is a mystery.

But the cause of his distress yesterday was clear. Medicaid, which helps nearly one in every four Americans and could be a lifeline for my patient, is under attack.

Despite working hard for most of his life, Mr. M is uninsured. His medicines are expensive and, without insurance, the odds of getting more intensive treatment are slim. Hoping to change the odds, he applied for Medicaid. But now plans like the State Flexibility Act are working their way through Congress, on the heels of the recently defeated Ryan budget plan. And 2012 federal budget negotiations are starting with a $100 billion cut to Medicaid. These proposals will make it easier for states to kick people off Medicaid and reduce eligibility, keeping people like Mr. M away. Instead of trying to improve health care and help those in need, some are debating ways to take the lifeline of Medicaid away from seniors, the disabled, low-income adults and children. That's a prescription for disaster.

Most Americans agree. A poll by the Kaiser Family Foundation found that only 13 percent of Americans would support major reductions in Medicaid spending as part of Congress' efforts to reduce the deficit. A majority, 53 percent, want to see no reductions in Medicaid spending at all.

This support is well-founded. One out of every two Americans has either received Medicaid benefits, like direct health coverage, long-term care, or Medicare premium assistance, or knows a relative or close friend who has. Many realize what the Center on Budget and Policy Priorities has confirmed. Medicaid is cost-effective. After adjusting for health differences among enrollees, the per-capita costs of Medicaid for children and adults are 27% and 20% cheaper, respectively, compared to private insurers.

Yet, at a time when Americans like Mr. M need it most, Medicaid is under attack. At least 25 states are trying to further cut benefits and provider rates, restrict eligibility or increase cost-sharing for the poor. Through the State Flexibility Act, some lawmakers want to repeal a component of the Affordable Care Act which requires most states to preserve current eligibility levels and enrollment procedures for most adults and children. If passed, it will mean that community clinics like ours which have managed to stay open despite massive state budget cuts will have a hard time staying afloat. Without access to care, Mr. M is more likely to end up in overburdened emergency rooms or hospitals.

Whether by intent or irony, these and similar block-grant plans will restrict opportunity in the name of "state flexibility" by cutting care, prolonging illness, and driving up health care costs. The risk is real. If Congress jettisons Medicaid in budget reconciliation or in a deal to extend the debt limit, tens of millions of children, seniors and the disabled will face catastrophic threats to their health and security.

Lawmakers would be wise to protect Medicaid, heed voter sentiment and consider smarter approaches to save costs and improve health care. First, states should take advantage of available enhanced federal funding to set up "health homes." These models not only better coordinate the care of chronically ill Medicaid beneficiaries but also drive down costs. A pilot Medicaid medical home program saved North Carolina nearly $170 million in its first year. Illinois saved $220 million in a similar program over two years and an additional $300 million over 3 years by helping Medicaid patients with chronic diseases adhere to their medicines. States should also align funding and "health home" models to scale up prevention initiatives like Community Transformation Grants, made available under health reform to help local communities address root causes of costly disease. With fast-track support offered by the US Department of Health and Human Services, states can scale up community-based care managers, who can significantly reduce unnecessary patient visits to emergency rooms and hospitals by coordinating prevention and treatment. A care management initiative in California reduced hospital admissions due to asthma by 90%. Lastly, states should raise the bar set by the Affordable Care Act by further incentivizing Medicaid providers to reduce avoidable complications, like hospital-acquired infections. These measures will lower costs and improve outcomes for our sickest relatives, neighbors, and communities.

Protecting and improving Medicaid is an uphill battle, in large part because children and the disabled lack political power. So efforts to bring the voices of patients like Mr. M and providers into the democratic process are vital. The question is whether our leaders have the political and moral courage to listen. Our nation's health depends on it.

Rishi Manchanda is founder of Rx Democracy!

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Forget the weird sex escapades of members of Congress, this is the story we should be talking about (and it's hardly even on the media map):

THE HPV VACCINE AND THROAT CANCER

Can HPV vaccines stop the explosive rise of HPV-related HEAD AND NECK CANCER?

HPV (human papillomavirus) vaccines protect against the sexually transmitted strains of HPV that cause cervical cancer. The same HPV strains -- spread by kissing and by oral sex -- cause OROPHARYNGEAL (OP) CANCER, the form of head and neck cancer that affects the back and sides of the throat, the base of the tongue, and the tonsils.

There's strong evidence that HPV vaccines prevent cervical cancer. There's no direct proof that these vaccines prevent throat cancer, but the rapid rise in cases among young people has some experts wanting to vaccinate first and get proof later.

"We don't need to wait until all these molecular events are understood," said Dong Moon Shin, MD, of Emory University's Winship Cancer Center. "The time is now. For the HPV vaccine, cost is the only issue as side effects are minimal. Routine HPV vaccination has to be implemented very soon, for both boys and girls."

In the U.S., that recommendation is made by the Advisory Committee on Immunization Practices (ACIP). The ACIP now recommends routine HPV vaccination only for girls and young women in order to prevent cervical cancer. It permits vaccination of boys who want protection against HPV-caused genital warts.

For two years, the ACIP has been mulling whether to recommend the HPV vaccine for boys. This would help prevent CERVICAL CANCER in unvaccinated women. It also would prevent HPV-related ANAL CANCER and genital warts in both men and women, as well as HPV-related PENILE CANCER.  But HPV causes anal cancer and penile cancer far less often than it causes cervical cancer, and if enough girls were to get the HPV vaccine -- about 50% -- it wouldn't be cost-effective to vaccinate boys.  Throat cancer is rapidly changing this scenario.

Throat Cancer Tipping Scales Toward HPV Vaccination of Boys

The ACIP recently heard a disturbing report from Aimee Kreimer, PhD, an expert in head and neck cancer at the National Cancer Institute.  "At some point ... it is projected that there will be the same incidence of OP cancer in men as cervical cancer in women," Kreimer said. "If current trends continue, OP cancer in men will pass cervical cancer in 2025."

And HPV is to blame. Only a few decades ago, the major risk factors for throat cancer were smoking and alcohol. Not any more. In the five-year period of 1984-1989, only 16% of OP cancers were linked to HPV. By 2000-2004, HPV was behind 75% of OP cancers.

Not all the risk factors are known, but HPV-related throat cancer risk goes up with increased oral sex and kissing, Kreimer said. Current tobacco use and HIV infection also are risks.

Fortunately, oral HPV infection appears to be much less common than genital HPV infection. Among healthy individuals infected with HPV, fewer than one in 20 has detectable HPV in the oral cavity.  But there are disturbing trends. Husbands of women with cervical cancer have a threefold higher risk of tonsil cancer. And people who have anal cancer have a fourfold to six-fold higher risk of tonsil cancer.

These findings are tipping the ACIP in favor of recommending routine HPV vaccination for boys.  "Most members of the [ACIP] HPV working group favor the strategy of routine vaccination of all males at the age at which they get the most benefit," Eileen Dunne, MD, MPH, a CDC researcher assisting the working group, said in a presentation to the full ACIP.

But the ACIP did not vote on the issue at the June meeting. Some members of the panel expressed frustration with the process.  "HPV cancers in males account for 7,000 cases a year," said ACIP member Mark H. Sawyer, MD, professor of pediatrics at the University of California, San Diego. "That is not a trivial number, and we are sitting around here wondering whether to immunize them. But it is not a trivial question."

The National Cancer Institute estimated that in 2010, there were 12,660 cases of OP cancer -- and 2,410 deaths. About half of those cases would have been male; at least three-fourths would have been caused by HPV.

The full ACIP likely will vote on the issue at its October meeting.

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On last week's "White Collar", one of the characters said something along the lines of "If someone's trying to kill you, paranoia might be a good idea".  The following piece in The New York Times brought that line to mind.  It's the timing ...

F.D.A.URGES LESS USE OF ANEMIA DRUGS

By Gardiner Harris

Federal drug regulators said that three drugs that had been widely used to treat anemia in both kidney and CANCER patients were so dangerous to the heart that doctors should consider avoiding the medicines altogether in some patients and using less of them in others

The Food and Drug Administration concluded that there were no risk-free doses of Epogen, Aranesp and Procrit, and that doctors should use the medicines only in patients suffering from severe anemia.  Doctors have used the medicines in the past to make patients feel better as a way to increase CHEMOTHERAPY doses in cancer patients.

But there is growing evidence that the drugs may have cost many patients their lives by causing deadly strokes and other heart problems, as well as speeding the growth of cancer tumors.

"This is a very big deal," said Dr Jay Wish, a professor of medicine at Case Western Reserve University in Cleveland.  "It's going to hit the dialysis population right now in a big way."

The medicines have cost the federal government more than $60 billion since they were introduced in 1989, and for years they were the biggest single drug expense in the federal Medicare program.  The medicines have been big money makers for oncologists -- who earn a mark-up for many of the medicines they prescribe -- as well as dialysis providers.

But as Congress debates ways of saving money in the Medicare program, some critics have pointed to these medicines -- known collectively as erythropoietin-stimulating agents -- as examples of how poorly the federal government controls expenses in the program.  The United States is among only a few industrialized countries that do not routinely assess whether new drugs or devices are worth providing to patients whose care is paid for by the government.  Those decisions are largely left up to doctors, many of whom have financial incentives to use the drugs or devices.  Indeed, doctors in the United States used far more Epogen, Aranesp and Procrit than doctors in Europe and elsewhere who did not profit from their use.

"Sixty billion dollars have gone out the window on those drugs and what do we have to show for it?" asked Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit health policy research institute in Bethesda, Md.  Citing government estimates that as much as $800 billion in health care expenses may be wasted annually, Mr. Cotter said, "It's time we had a sound way of assessing the value of these technologies."

Amgen, a large biotechnology company, was built on the sales of Eopgen and Aranesp.  Johnson * Johnson sells Procrit, which is manufactured by Amgen.  Dr. Roger M. Perlmutter, executive vice president for research at Amgen, said the company supported the new F.D.A. Warnings, which will be placed on the labels that educate doctors.

"The revised label also provides physicians with more individualized treatment guidance by distinguishing between patients undergoing dialysis as compared with those who are not on dialysis," Dr. Perlmutter said.

Epogen, Aranesp and Procrit work by spurring the body's production of red blood cells, which ferry oxygen to the body's tissues.  Professional athletes, particularly cyclists, have used the drugs (often improperly) to improve performance.  They were developed to help dialysis patients cut down on blood transfusions, but Amgen and Johnson & Johnson soon persuaded doctors that the drugs helped both kidney and cancer patients feel better even when not suffering severe anemia.  The consulting payments that the companies made to top doctors, including those who wrote guidelines for the drugs' used, may have played an important role in doctors' enthusiasm.

The drugs are expensive, and that means they have been particularly profitable for oncologists and nephrologists.  But sales have been falling since 2007, when studies renewed concerns that the drugs might cause heart attacks and strokes and spur the growth of cancer.

Friday's warning about the drugs' risks is the most severe yet and will likely reduce uses of the drugs in kidney patients by as much as a third, Dr. Wish said.

"I think it's fairly draconian and is an overreaction," said Dr. Wish, who has consulted for makers of the drugs.  "They're scaring everyone away."

Dr Daniel Coyne, a professor of medicine at Washington University in St. Louis, asked why any patient would willingly risk a fatal stroke or heart attack just to reduce the number of blood transfusions they might require while on dialysis.  He said he would probably cut the dose of the medicine he provided to dialysis patients by a third or more and eliminate it from the care of many patients not yet on dialysis.  He and other nephrologists predicted that the F.D.A. warning would change the way Medicare paid for the drug.

"This is a shockingly bold statement by the F.D.A., but is firmly evidence-based," Dr. Coyne said.

(I'm going to go with my oncologist's opinion on this.)

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Enjoy your summer and Stay Healthy!

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And if you have any thoughts of how this newsletter could be improved, please email me directly, at jesmer_e@pacbell.net

Elaine Jesmer

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