26 June 2010

Hope Grows out of a Brick Wall in Boston

Boston Globe

In a crowded, walled-off section of City Hall Plaza yesterday, Anne Gagne and Caroline Marchant took photos of a small plaque memorializing their mother, Micheline M. Gagne, who succumbed to lung and brain cancer last year.

“Gardens represent life and death too, because things die and grow,’’ Marchant said.

Gagne’s plaque is one of hundreds on the brick wall lining the new Cancer Garden of Hope in City Hall Plaza, which was formally dedicated yesterday.

More than 200 people came to the ceremony. Roses and purple clematis growing atop the brick walls that enclose the garden were admired by the crowd.

“The City of Boston has more heart than concrete in there,’’ said Jonathan Zuker, cofounder of the Conquer Cancer Coalition of Massachusetts, which headed the effort. “Thanks to you, hope grows here.’’

Zuker was joined by his brother, mother, Mayor Thomas M. Menino, and representatives of cancer organizations including the Friends of Mel Foundation and Thrive who all spoke at the dedication ceremony.

The garden is “a great tribute to individuals who walked the line and faced this issue,’’ said Menino, who was successfully treated for skin cancer in 2003.

Debbie Centracchio, also a cancer survivor, and her husband, Al, came in memory of a friend who died of the disease in February. Promoting hope was as important as paying respects, Al said. “A lot of people can see that you can survive breast cancer,’’ he said sitting next to Debbie, who was diagnosed 15 years ago.

The idea of healing gardens inspired the cancer garden of hope, Zuker said after the ceremony. The plaques displaying names of cancer victims and their supporters can serve as a metaphor for the waiting rooms in which his family and others affected by the disease spent time supporting each other.

Zuker founded the Coalition with his mother, Susan, and brother Matthew in 2004, the year his father, Michael, to whom the garden is dedicated, died of lung cancer. Since 2006, the Coalition has raised $350,000 for local cancer organizations with “conquer cancer’’ license plates sold through the Registry of Moter Vehicles, he said.

Using some of that revenue and all the money generated from the sales of plaques, the Conquer Cancer Coalition raised $100,000 yesterday, Zuker said. The wall provides new hope for Dearborn cancer treatment.

Anne Lynch of Hampstead, N.H., who lost a husband and sister-in-law to cancer, finds the community aspect of the garden important. “We are all one, we’re all brothers and sisters in cancer,’’ Lynch said.

24 June 2010

Avoid Getting Burned by Sunscreen Ratings

The Baltimore Sun

Temperatures are rising and beach season is in full swing — which means consumers are stocking up on sunscreen.

But it's not as easy as S-P-F.

Store shelves are loaded with sprays and lotions with SPFs, or sun protection factors, approaching triple digits. Some protect against sunburn but not long-term skin damage. Then there's recent research that found all but a sliver of sunscreen products less effective than manufacturers claim — and even potentially dangerous.

And with all that confounding consumers, medical experts worry that claims of high-level protection could lull consumers into a false sense of security or fears about safety could deter them from using sunscreen altogether.

"Basically, having any kind of protection is better than no protection," said Dr. Ali Hendi, a board-certified dermatologist, surgeon and skin cancer expert in Chevy Chase.

SPF is a measure of protection against UVB rays, which cause burns. If your unprotected skin burns after 10 minutes of exposure, an SPF of 30 that's recommended by many experts would theoretically increase your protection to about 300 minutes. The protection could be shorter-lived, though, as sunscreens become less effective as they rub off with activity, according to the American Academy of Dermatology.

In a study released last month, the Environmental Working Group, a nonprofit public health advocacy group, recommended only 8 percent of 500 sunscreen products it evaluated for effectiveness and safety.

While one in six products now features SPFs higher than 50, EWG research analyst Nneka Leiba contends that most people never put on enough to reach the intended protection level. Nor, she says, do most people reapply every two hours as recommended. The amount of sunscreen manufacturers use in testing is four to five times what people normally use, Leiba added.

"They have a false sense of security of how much protection they're getting and stay out in the sun a lot longer," Leiba said. Her recommendation to consumers on the amount of sunscreen to apply: "Just use two or three times what you think would be enough."

The industry defends the labeling on sunscreens and says the EWG report had serious shortcomings because of questionable scientific methodology.

"The [manufacturers'] testing and SPF number takes into account that real-life use," said Farah K. Ahmed, chair of the sunscreen task force for the Personal Care Products Council, which represents the manufacturers.

Beyond the debate over sunburn protection is the sometimes-overlooked need to also protect against UVA rays, which account for the vast majority of UV radiation to which people are exposed and can lead to premature wrinkles and age spots.

Consumer Reports, in the July issue of its magazine, tested sunscreen sprays and how well they provide what is called "broad spectrum" coverage against both UVA and UVB rays.

The nation's annual toll of skin cancer is more than 1 million cases and more than 11,000 deaths from the disease. UV radiation, much of it from the sun, is the biggest cause of the condition, according the American Cancer Society.

The Detroit skin cancer treatment rate, in addition to concerns about ingredients and labeling, has prompted calls for the federal government to develop better rules to govern the sunscreen industry.

Without better federal oversight, manufacturers "have a long rope with which they can run," said Leiba, the EWG research analyst.

Sunscreens are currently regulated by the Food and Drug Administration as an over-the-counter drug, which covers ingredients, doses, formulas and labeling. New rules involving testing and labeling about UVA protection are expected to be approved in October; manufacturers would have a year to comply.

FDA spokeswoman Shelly Burgess said a 1993 FDA rule never went into effect because it only addressed UVB rays, not UVA rays. And a rule proposed in 2007 that covered UVA exposure generated a lengthy public debate. "It's just taken longer than originally anticipated and more FDA resources to get that done," she said.

Last month's EWG report involves an ingredient designed to slow skin's aging process — a vitamin A derivative called retinyl palmitate — that is found in many sunscreen products. The EWG research points to an FDA study that indicates the ingredient can promote the growth of cancerous tumors.

That drew protests from the Skin Cancer Foundation that the EWG report could discourage people from using sunscreen altogether. That organization's photobiology committee reviewed the data and determined that retinyl palmitate is not a photocarcinogen, according to a statement on its website.

Beyond the debate over sunscreen's science and regulations, consumers should still defer to common sense by wearing protective clothing and avoiding peak sun hours, medical experts advise.

Hendi, the surgeon and skin cancer expert in Chevy Chase, recommends people use densely woven sun-protective clothing to cover their chest, back and arms when they know they will be out in the sun.

He added that "sunscreens do a great job of blocking out the rays." Consumers just need to use them — and reapply, he said.

By the numbers

30: all the SPF you need

39: number of sunscreen products recommended out of 500 evaluated by the Environmental Working Group

4: number of sunscreen sprays among 12 tested and recommended by Consumer Reports

68,720: number of new cases of melanoma, the deadliest form of skin cancer, reported in 2009

1 in 50: number of Caucasians who will get melanoma. The rate is 1 in 1,000 for African-Americans and 1 in 200 for Hispanics.

Source: American Cancer Society, the Environmental Working Group and Consumer Reports

Sunscreen tips

Buy a broad-spectrum sunscreen that protects against both UVA and UVB rays.

Apply sunscreen to exposed skin on a daily basis, even when it's a cloudy day or when you plan to stay mostly indoors.

Avoid the sun during the peak hours of 10 a.m. to 4 p.m. When outside, wear a hat, sunglasses and sun-protective clothing.

Apply sunscreen 15 to 30 minutes before going outside, so the product can adhere and absorb into your skin. And use plenty — at least one ounce, about a shot-glass full.

Reapply sunscreen every two hours, or after swimming, drying off or sweating a lot.

Foundation Launches New Rheumatoid Arthritis Screening Program

NJ Today

The Arthritis Foundation announced today the start of a new pilot program designed to improve the early diagnosis of rheumatoid arthritis (RA). The goal of the program is to decrease the number of people with inflammatory arthritis who become disabled due to the lack of early diagnosis and treatment.

The foundation has set up a toll-free number, 1-866-720-4297, to offer New Jersey-area residents the ability to take a specially designed screening questionnaire to help them learn if they need follow up care from a health care provider who specializes in rheumatoid arthritis treatments.

“The Arthritis Foundation wants to assist people living with joint symptoms to learn if they need further treatment to prevent disability from inflammatory arthritis,” said Dr. Patience White, Vice President, Public Health with the Arthritis Foundation. “There are new effective treatments for rheumatoid arthritis relief so making the diagnosis and starting appropriate treatment early is crucial to preventing permanent joint damage.”

The Arthritis Foundation offers the following additional facts about rheumatoid arthritis:

    * Rheumatoid arthritis (RA) is an auto-immune disease which affects 1.3 million people in the U.S.

    * There are 2.5 times as many women as there are men with RA.

    * Onset of RA is usually middle-age, but it often occurs in the 20s and 30s.

   * The Arthritis Foundation reports that thirty to forty percent (30-40%) of people with RA experience work loss within five years of diagnosis. Within 10 years this figure doubles to sixty percent (60%).

23 June 2010

Federal Health Care Site Coming July 1

USA Today

Wish finding health insurance were as easy as shopping for an airline ticket?

A federal government website that starts July 1 takes a step in that direction. The site, for the first time, will give consumers a list of all private and government health care plans for individuals and small businesses in their areas.

The nation's new health care law requires the site (www.healthcare.gov). Initially, it will provide just basic facts, such as the names of companies, health plans and Web links. Beginning in October, it will list detailed cost and benefits information. Consumer groups and insurers already are clashing over exactly what information should be displayed.

"What we are trying to do is create some order in the marketplace," says Karen Pollitz, a top official at the new Office of Consumer Information and Insurance Oversight at the Department of Health and Human Services. She acknowledges the site won't be the Expedia of health care any time soon: "This ain't like buying a plane ticket; it is much more complicated."

For example, unlike the popular travel sites where people can immediately buy an airline ticket, consumers will have to contact insurers directly to sign up.

Insurers including UnitedHealthcare and Aetna say HHS is going too far in planning to list certain data, such as the percent of claims that health plans deny, the rate at which they cancel policies after customers get sick and the number of times patients appeal coverage decisions. They say the data would mislead potential customers.

"Let's do what the legislation sets out and not overcomplicate, which will lead to consumer confusion and higher costs," says Aetna spokesman Mohit Ghose.

Consumer groups such as AARP and Families USA counter the data are vital in helping people pick a plan.

The site can "be the great equalizer so consumers can have equal access to information and be on the same playing field as insurance companies," says Elisabeth Benjamin, co-founder of Health Care for All New York, a consumer health care coalition. "The government needs to make the information as open as possible."

The site aims to help consumers navigate the insurance market. The main part of the health overhaul law takes effect in 2014, when there's a major expansion of insurance coverage and the creation of new state-based health insurance exchanges, which are marketplaces to make it easier for individuals and small businesses to buy insurance. These exchanges will have their own websites.

"It is a very important first step to give consumers the information they need … so insurers are competing on quality of care and customer service," says AARP lobbyist Paul Cotton.

HHS has said that in October, when it will begin listing premiums for insurance plans, it will use what Pollitz calls "sticker prices." Actual rates could be significantly higher based on an individual's health status. Until 2014, insurers are allowed to charge sicker people more, and to deny applications altogether.

UnitedHealthcare is concerned that consumers could misinterpret even those base prices. The company wants the site to list average prices.

Meanwhile, consumer advocates such as Benjamin say consumers should be able to get exact prices from insurers on the site. That could require patients to submit detailed medical histories — at least until 2014.

22 June 2010

U.S. FDA Demands Philip Morris Marketing Documents


U.S. regulators demanded on Thursday that cigarette maker Philip Morris turn over all market research material on Marlboro Lights, citing concern over an advertisement for the brand.

In a letter to Philip Morris parent company Altria Group, Inc, the U.S. Food and Drug Administration said it was concerned about advertisements, or "onserts," attached to packs of Marlboro Lights.

A U.S. ban on promoting cigarettes as "light," "mild" or "low" takes effect on Tuesday. The ban is a key provision of a new federal law that gives the FDA authority to regulate tobacco products.

"By stating that only the packaging is changing, but the cigarettes will stay the same, the onsert suggests that Marlboro in the gold pack will have the same characteristics as Marlboro Lights, including any mistaken attributes associated with the 'light' cigarettes," the FDA letter read.

Altria must submit by July 30 all materials related to the marketing or sale of Marlboro Lights, including themes, creative recommendations and dissemination strategies, the FDA said.

Altria spokesman Bill Phelps said, "We received the letter today and we're reviewing it and we will respond."

The anti-smoking group Campaign for Tobacco-Free Kids said the FDA action would prevent Philip Morris from evading the ban.

"This will give the FDA the information it needs to take additional enforcement action if Philip Morris does not pull the onserts," the group said in a statement.

21 June 2010

FDA Fines Red Cross $16M after Blood Safety Inspection

LA Times

The federal agency said the charity failed to maintain quality controls in collecting and processing blood products in 2008 and 2009.

The Food and Drug Administration on Thursday fined the American Red Cross $16 million, alleging that the organization had been slipshod in the collection and manufacture of blood products. It was the latest in a string of multimillion-dollar penalties for failure to meet blood safety standards.

Despite the most recent violations, there is no indication that patients or the blood supply were endangered, "and the blood supply is believed to be safe," the FDA said in a statement.
The penalties resulted from FDA inspections of a dozen Red Cross facilities across the nation in 2008 and 2009 that identified multiple failures to investigate and correct sloppy processing of blood products and a failure to maintain quality controls.

The FDA said that it was encouraged by recent actions by the Red Cross' leadership to improve blood safety and that it was "hopeful these fines will encourage the Red Cross to act more quickly" to comply with safety regulations.

The fines bring to $37 million the total penalties for substandard blood handling procedures levied against the Red Cross since 2003. In that year, a consent decree in place since 1993 was amended to let the FDA impose fines.

In a statement, the Red Cross said many of the incidents cited by the FDA took place before corrective action was taken.

The Washington-based charity said it was "fully committed to meeting all FDA standards" but was "disappointed that the FDA believed that it was necessary to fine us for prior violations dating back several years."

The Red Cross collects and processes about 43% of the nation's blood supply and produces blood products including red cells, plasma and platelets.

A Red Cross spokeswoman said fines were paid out of the agency's operating budget, which comes from fees paid by hospitals for blood services, and not from donations.

FDA Endorses ellaOne Morning-After Pill

The Washington Post

U.S. government health experts voted Thursday to endorse a new type of morning-after contraceptive pill that works longer than existing products, concluding that it is safe and effective.

The unanimous recommendation from the Food and Drug Administration's panel of reproductive health experts moves the pill ellaOne, which is approved in Europe, one step closer to the U.S. markets. The FDA is not required to follow the panel's advice, although it often does.

EllaOne successfully reduces the chance of pregnancy for up to five days after sex. Plan B, the most widely used emergency contraceptive pill, is effective only if women take it within three days of having sex.

EllaOne has drawn criticism from anti-abortion groups, which say the drug is closer to an abortion pill than emergency contraception.

Vitamin B6 Linked to Lowered Lung Cancer Risk

U.S. News & World Report

While it may be a bit early to start popping supplements, a new study finds that people with high levels of vitamin B6 may be less likely to develop lung cancer than those with low concentrations. Reporting in the June 16 Journal of the American Medical Association, researchers also note a seemingly protective effect from high levels of the essential amino acid methionine and a weaker healthful effect from high levels of folate, another B vitamin.

It’s not yet established how high amounts of these compounds might protect the body from lung cancer, but all three are involved in the maintenance of DNA. In the vast majority of lung cancer cases, toxic smoke causes the DNA damage and aberrant cell growth that marks the disease.

Researchers tapped into a massive database of medical information and blood test results obtained from more than 380,000 Europeans in the 1990s. Using medical registries, the researchers identified 899 people in the study who had developed lung cancer during 12 years of follow-up. For each cancer patient, the scientists randomly selected as a comparison group two people without cancer from the database — matching these controls to the cancer patients in age, gender, country of origin and time of entry into the study.

Paul Brennan of the International Agency for Research on Cancer in Lyon, France, and an international team of researchers calculated that people with vitamin B6 levels ranking in the top one-fourth of all the samples taken had less than half the risk of lung cancer as those with the lowest vitamin B6.

A similar comparison found that people with high levels of methionine seemed to have almost half the cancer risk of people with low levels. High folate levels seemed to give less protection. But having stellar levels of all three compounds lowered a person’s risk of lung cancer by a full two-thirds, the scientists calculated, after accounting for whether they were a smoker, former smoker, or a never-smoker.

The findings may indicate that long-term exposure to the vitamins is the key, says Graham Colditz, a physician and epidemiologist at Washington University School of Medicine in St. Louis. But that doesn’t mean that simply taking vitamins for a few years would make any difference, he says. “This might reflect diet and internal exposure [to these compounds] in the body over decades before the study began.”

A smaller study published in 2001 similarly hinted at protection against lung cancer by high vitamin B6 levels. More recently, several studies suggested a protective effect of vitamin B6 against colorectal cancer. But tests of folate against cancer have shown mixed results, and little research has been done to date assessing the impact of methionine levels on cancer risk.

Even if the results in the new study are real, it remains unclear whether vitamin supplements could provide the same protection as food sources of vitamin B6 and methionine — or whether natural sources of these compounds would work better, Colditz says. Vitamin B6 is found in beans, grains, meat, poultry, fish and to some extent in fruits and vegetables. The main sources of methionine are animal products, with fruits and vegetables providing less.

In any case, the authors note, further clarification that vitamin B6 actively prevents lung cancer — even in smokers — should not “detract from the importance of reducing the numbers of individuals who smoke tobacco.”

Merck KGaA Resumes Vaccine Trials in Lung Cancer


Germany's Merck KGaA and its U.S. partner Oncothyreon have resumed testing their experimental cancer vaccine Stimuvax on lung-cancer patients, reviving hopes for a key pipeline drug.

The U.S. Food and Drug Administration (FDA) lifted the hold it had placed on a Phase III trial called START in non-small cell lung cancer, Merck said on Thursday.

Merck and Oncothyreon also continued their INSPIRE study, which targets Asian lung-cancer patients, but the Phase III STRIDE trial in breast cancer remained suspended, it added.

Merck on March 23 stopped all tests of the vaccine on humans after a patient contracted encephalitis in another setback at the drugs unit from which Merck is trying to diversify.

Oncothyreon shares plummeted 27 percent that day and have not recovered since.

Before Wall Street opened on Thursday, the biotech firm's shares were up 6.9 percent in Frankfurt at 1002 GMT. Merck KGaA shares edged 0.1 percent lower.

"It is good news for Merck that the FDA has given the go-ahead to continue the trials in lung cancer," said WestLB analyst Cornelia Thomas.

"However, therapeutic cancer vaccines are generally high risk programmes ... we have never included any value for these programmes and will not do so now."

The first vaccine to treat cancer, Dendreon Corp's Provenge, won U.S. approval in April in a field that has been littered with failures.

Bristol-Myers Squibb as well as Transgene in an alliance with Novartis are also aiming to bring such compounds to market.

The case of brain inflammation that marred the Stimuvax programme emerged in a mid-stage trial with 30 participants where the vaccine was tested against multiple myeloma, a type of cancer affecting the bone marrow and white blood cells.

Stimuvax, based on an active ingredient known as BLP25, is designed to prime a patient's immune system against certain cancer cells after a tumour has been diagnosed.

20 June 2010

Decision Upheld to Bar California Nurses' Strike

Sacramento Bee

The California Nurses Association vowed to continue its fight with the University of California over staffing levels, saying it won't be deterred by a San Francisco judge's ruling Friday that bars nurses from staging a one-day strike.

San Francisco Superior Court Judge Peter J. Busch prohibited the union from staging strikes at the university's five medical centers until at least Sept. 30, when the current contract between the union and the university ends.

Two days before the union was to stage a June 10 walkout at UC-run hospitals, Busch intervened by issuing a temporary restraining order requested by the state Public Employment Relations Board on behalf of the university.

On Friday, the judge made his ruling permanent, saying that there was reasonable cause for PERB to believe that a strike would violate state labor laws.

The CNA walkout was intended to protest what the union said are unsafe nurse staffing levels – a charge the university denies.

At the center of the dispute is whether the university is complying with state-mandated nurse-to-patient ratios, which require at least one nurse for every five patients – and even more for patients with higher levels of need.

The dispute over staffing levels has long been a sticking point in negotiations.

"I'm hopeful that because of the judge's ruling, the CNA will sit down at the table so we can work out a really good contract for the nurses. We can do this in earnest instead of posturing," said Carol Robinson, chief nursing officer for UC Davis Medical Center.

The CNA represents nearly 11,000 registered nurses employed by the university, including 1,800 at the UC Davis Medical Center.

University officials commended the judge's decision, but the setback upset union officials.

"We're going to continue fighting for proper staffing levels. We're not going to stop," said Beth Keane, the CNA's lead negotiator for the union's university labor contracts.

She said the union plans to file complaints with the state Department of Public Health. The state agency, however, has yet to act on a complaint filed by the union in November over staffing levels at the UC Davis Medical Center.

The university said it had already spent $8.4 million preparing for a possible walkout by nurses.

Walgreen, CVS Agree to Continue Pharmacy Benefit Deal

USA Today

CVS Caremark and Walgreen have settled a contract dispute that had been expected to prompt thousands of Walgreen customers to search for a new place to fill drug prescriptions.

Details of the deal announced Friday were not disclosed. Shares of both companies surged in premarket trading.

Both companies have been negotiating for months and earlier this month said they would end their partnership. That partnership allows people whose prescription drug benefits are handled by Caremark to be reimbursed for prescriptions filled at Walgreen's pharmacies. Walgreen has more than 7,500 outlets.

CVS Caremark (CVS), based in Woonsocket, R.I., said Walgreen's participation means the CVS Caremark national pharmacy network will have more than 64,000 participating pharmacies.

Walgreen (WAG), based in Deerfield, Ill., is the largest U.S. drugstore chain based on locations and revenue, slightly ahead of CVS Caremark.

Walgreen wanted to be paid more for filling prescriptions. Caremark makes money by reducing costs for plan members and sponsors.

"We are very pleased with the outcome of this mutual, multiyear agreement that meets our business objectives," Kermit Crawford, executive vice president of pharmacy for Walgreen, said in a statement. "The agreement makes good business sense, provides the framework we need to operate our business going forward, and assures choice and convenience for the many consumers who look to us for quality pharmacy care."

Caremark has one of the largest pharmacy benefits management networks. It negotiates contracts with employers and handles the drug benefit part of their health plans, paying pharmacies to fill prescriptions. It saves money by negotiating volume discounts.

"We are pleased to have reached a mutually agreeable solution together with Walgreens that is consistent with our top priority to provide convenient access to affordable high-quality pharmacy health care," Per Lofberg, president of CVS' pharmacy benefit management business, said in a statement.

18 June 2010

A Sex Pill for Women? U.S. Panel Debates Possible Benefits


A pink pill that acts on brain chemicals has helped women with low sex drive, its German manufacturer said on Friday, arguing for the first U.S. approval of a drug to boost women's libido.

Officials of privately held drugmaker Boehringer Ingelheim aimed to convince an expert panel, over the doubts of government reviewers, that the pill offered meaningful benefits to women who want a medical option to increase their sexual desire.

The once-a-day pill called flibanserin is the latest attempt at a female counterpart to Pfizer Inc's Viagra, the blockbuster blue pill for men. In clinical studies, Viagra and other male impotence pills have failed to help women.

Boehringer is seeking Food and Drug Administration approval to sell the pill by prescription for premenopausal women with a persistent, bothersome and unexplained lack of sex drive.

"Women deserve the option to choose a safe and effective pharmacological therapy for this distressing condition," said Dr. Anita Clayton, a Boehringer consultant and psychiatry professor at the University of Virginia.

The company must overcome major concerns from FDA reviewers. In an analysis released on Wednesday, agency staff said the drug failed to boost sex drive in two studies as measured by women's diary entries.

Women did report slightly more satisfying sexual experiences -- an average of 4.5 per month compared with 2.8 before taking the medicine. For placebo patients, the rate jumped to 3.7 during the studies.

The drug's tolerability was "only moderate," FDA staff said. Nearly 15 percent of women who took the recommended flibanserin dose stopped doing so before the study ended due to possible side effects. Depression, fainting and fatigue were among the problems reported by women who took the drug.

Boehringer said most of the reported problems were mild.

The company also said an analysis based on women's answers to questions about their response showed a jump in sex drive and lower distress levels with the drug.

The advisory panel, a group of experts from outside the FDA, will vote later Friday on whether to recommend approval of flibanserin. The FDA, which will make the final decision, usually follows panel recommendations.

The drug's proposed brand name is Girosa. It is not yet approved anywhere in the world.

Flibanserin, which was originally tested as an antidepressant, acts on neurotransmitters in the brain. Viagra and other pills to treat male impotence work by widening blood vessels to increase the blood flow needed for an erection.

Drugmakers have tried various approaches to boost female libido, but women's sex lives have proved more difficult to target with medication.

Procter & Gamble Co tried to win U.S. clearance to sell a testosterone patch to treat female sexual dysfunction. An FDA advisory panel voted in 2004 against recommending approval, citing a lack of evidence for long-term safety. The patch was approved in Europe and has been sold to Warner Chilcott.

Another U.S. drugmaker, BioSante, is developing a testosterone skin gel to treat a decline in libido in menopausal women. The company estimates the market for treating female sexual dysfunction in the United States tops $2 billion annually.

17 June 2010

J&J Expands January Recall to Add Benadryl, Tylenol

Bloomberg Business Week

Johnson & Johnson, under congressional investigation for a recall of children’s drugs, said it is expanding a separate January withdrawal of over-the- counter medicines to include lots that were “inadvertently omitted from the initial recall.”

The drugmaker’s McNeil Consumer Healthcare unit is recalling five product lots of Benadryl and Extra Strength Tylenol in addition to those announced on Jan. 15, New Brunswick, New Jersey-based J&J said today in a statement.

J&J is being investigated by the U.S. House Oversight and Government Reform Committee after pulling 40 types of children’s medicines on April 30. The January recall, of 500 lots of drugs including Rolaids, Motrin and some forms of Tylenol, was an expansion of a recall of Tylenol Arthritis Pain caplets announced in November 2009.

“This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson,” Representative Edolphus Towns, a New York Democrat and chairman of the oversight committee, said today in an e-mail. “I am troubled by what we have learned so far in our investigation and this latest development adds to my concern.”

Today’s recall involves four lots of Benadryl Allergy Ultratab Tablets, 100 count, sold in the U.S., and one lot of Extra Strength Tylenol Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda and Puerto Rico, J&J said in the statement.

J&J shares rose 72 cents, or 1.2 percent, to $59.14 at 4:15 p.m. in New York Stock Exchange composite trading. They have dropped 8.4 percent since Jan. 15.

Consumer Complaints

The January recall was the result of consumer complaints of a musty or moldy odor that has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets. The company received reports of nausea, vomiting and diarrhea after use.

The U.S. Food and Drug Administration sent a warning letter to J&J at the time, saying the drugmaker waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol sickened customers.

The medicine involved in that recall was made in J&J’s Las Piedras, Puerto Rico, manufacturing facility. The children’s medicines pulled this year were made in Fort Washington, Pennsylvania. The FDA is investigating all McNeil operations, and is closely monitoring J&J’s plan to correct its manufacturing lapses, Joshua Sharfstein, the agency’s principal deputy commissioner, said in May. The company may face seizures and criminal penalties, Sharfstein said.

Bonnie Jacobs, a spokeswoman for J&J, said the company had no further comment beyond its statement today.

AP-GfK Poll: More Republican Voters Supporting Health Care Reform

Associated Press

The vital signs are improving for President Barack Obama's health care plan.

The latest Associated Press-GfK poll on Obama's top domestic achievement finds support for the new overhaul has risen to its highest point since the survey started asking people about it in September — six months before it became law.

The results now: 45 percent in favor, 42 percent opposed. That's a significant shift in public sentiment considering that opposition hit 50 percent after Obama signed the health plan into law in late March and that in May, supporters were outnumbered 39 percent to 46 percent.

"I thought when people began to realize what was in the health care package that they would see it's a good, solid program and that would dispel some of the misinformation," said Brigham Young University English professor Claudia Harris, 72, of Orem, Utah.

Electrical contractor Kerry Eisley of Moscow, Pa., said he thinks people are starting to get nuts-and-bolts information on how the law affects them.

"If we can insure more people across the United States and get the cost of health care down, I think that's a better thing," said Eisley, 43, a Republican who supports the plan, which passed without the vote of any GOP lawmaker.

The poll found support increased since May among men (from 36 percent to 46 percent), people in their prime working years (from 35 percent to 49 percent among 30-49 year-olds) and Republicans (from 8 percent to 17 percent.) The uptick among Republicans comes even as party leaders are calling for the law's repeal.

The changes coincide with a concerted effort by the Obama administration, congressional Democrats and their allies to sell the immediate benefits of the law.

Among the selling points: coverage for young adults on their parents' plan until they turn 26; a $250 rebate check for older people with high prescription costs; tax credits for some small businesses that cover their employees; and federal money to train more primary care doctors and nurses.

"They are clearly making progress in convincing more Americans that this bill is the right way to go," said Robert Blendon, a Harvard University public health school professor who tracks opinion trends on health care.

Despite the gains, the prognosis for Obama and the Democrats is guarded.

"In my view, they can claim victory if it gets a majority," Blendon added. "The country is so polarized, it just might not make it."

The $1 trillion, 10-year health care remake puts the nation on a path to coverage for all. Starting in 2014, everyone in the U.S. will be required to carry health insurance. The government will provide tax credits to help middle-class people not covered at work buy a policy through new competitive health insurance markets. Medicaid will be expanded to help low-income people. The plan is paid for through a combination of Medicare cuts and tax increases.

One complication for the president is that older people remain opposed to the law. Just last week, Obama answered questions at a televised town hall meeting in a senior center, but his assurances seem to be having little effect. The poll found that 56 percent of people 65 and older don't like the new law.

"I don't know if it's sustainable, and that's got us worried," said Audrey Guillot, 69, whose family owns a general store in Pierre Part, La. "How much can we borrow? How long before other countries start calling in our debts? Medicare is about to go broke — when do you address that? How many bridges to nowhere can we build?"

The poll found that 51 percent trust Democrats to do a better job of handling health care, an issue that more than three-fourths rate as personally important to them. By comparison, 38 percent said they trusted Republicans.

Daniel Lowery, 23, a shipper at a Lowe's distribution center in Ohio, said he thinks Democrats "are headed in the right direction, for the most part." But he complained they haven't clearly explained how the complex law works.

"I think people would be more for it if they actually explained what they're giving us, because I barely know, and I watch news every day," said Lowery, who lives in Fostoria, south of Toledo.

The AP-GfK Poll involved landline and cell phone interviews with 1,044 randomly chosen adults and was conducted by GfK Roper Public Affairs & Corporate Communications from June 9-14. It has a margin of sampling error of plus or minus 4.3 percentage points.

16 June 2010

Companies Urged to Follow new Ohio Health Law

Associated Press

Advocates for the uninsured are urging some of Ohio's biggest employers to follow a new state law that allows young adults to stay on their parents' health insurance until they turn 28, even though the companies are exempt.

The law, which takes effect July 1, makes Ohio one of the few states to exceed the extension to age 26 mandated by President Barack Obama's health care overhaul. Young adults have one of the highest uninsured rates, often because they can't find jobs or because employers don't offer health coverage for entry-level positions.

Ohio's new benefit, while broad, won't help children whose parents work at private, self-insured companies that pay their workers' medical claims directly rather than buy insurance. These firms, including Procter & Gamble Co. and Honda Motor Co., fall outside state regulation.

About 6.6 million Ohioans get health insurance through employer-based coverage, and about half of those are with employers that self-insure.

It's disappointing that some of Ohio's largest employers will not voluntarily extend coverage for young adults to age 28, said Cathy Levine, executive director of the Universal Health Care Action Network of Ohio.

"We all benefit from having more young adults, who tend to be low-cost, in the insurance pool," she said.

Self-insured companies generally have multistate operations, and to offer health benefits in Ohio that aren't available to employees and their children in other states could be very confusing and administratively difficult, said Carrie Haughawout, who tracks health care policy at the Ohio Chamber of Commerce.

For now, companies such as the Cleveland Clinic, which has 28,000 employees on its self-insured health plan, are sticking with the federal regulation and will cover dependents up to age 26 only. Same with Eaton Corp., a large Cleveland-based company that makes hydraulics and electrical equipment.

Procter & Gamble, the consumer products giant based in Cincinnati, declined to comment on future plans, and Honda, which has four major auto factories in Ohio, said it still is evaluating the state changes.

The new state law will definitely fill a gap for some young adults ages 26 to 28, said Brian Gay, a 26-year-old graduate student at Ohio State University.

"Without health insurance, you cross your fingers and hope nothing happens to you," said Gay, who graduates Sunday and is covered under a school-sponsored health plan for the next three months. He'll explore coverage options with his parents if he can't land a job this summer that offers health benefits.

Ohio previously allowed dependent children to stay on their parents' health insurance until age 19 — or age 23 for a full-time student. New York allows parents to continue covering children up to age 29 in certain cases; Florida and Nebraska up to age 30; and New Jersey 31.

The federal mandate to extend coverage for young adults up to age 26, regardless of a company's self-insurance status, takes effect Sept. 23. About 1.2 million young adults nationwide are expected to sign up, more than half of whom would have been uninsured.

Ohio's law complements that, although married children aren't eligible. The new benefit should allow about 20,000 additional young adults up to age 28 to have access to health insurance, according to state estimates.

It could be more if companies that are exempt agreed to meet the standard on their own.

State regulators are unaware of any self-insured companies voluntarily taking that step, said Carly Glick, spokeswoman at the Ohio Department of Insurance.

Companies aren't on the hook for paying the added cost of extending coverage for young adults to age 28. That falls on employees who enroll their children, and prices will vary depending on individual plans.

Government workers looking to add coverage for older children are among the biggest beneficiaries of Ohio's law, including employees of Ohio State University and the state of Ohio. Even though both operate self-insured health plans, they are public institutions subject to state regulation.

The state of Ohio has about 58,000 employees and provides insurance coverage to 120,000, which includes beneficiaries, said Ron Sylvester, spokesman at the state Department of Administrative Services.

The added cost for a state employee who wants to maintain on a dependent child until age 28 ranges from about $136 per month to $150 per month, he said. About 415 new dependents already have been enrolled for the new benefit, and 259 more additions are pending.

Health Insurance, Check. But What about Dental?


An estimated 45 million Americans do not have dental insurance, according to a government report released on Wednesday, and recently passed healthcare reform offers little direct help.

Overall most non-elderly people who already have private health coverage also have a dental policy, but roughly 70 percent of those who have to buy their own health plan do not, according to the Centers for Disease Control and Prevention report.

Under the health reforms passed in March, adults must buy health insurance or pay a fine starting in 2014. The law does not require them to buy other types of coverage like dental or vision, although some comprehensive health care plans include the additional coverage.

While health plans must cover at minimum services like emergency care and prescription drugs, they do not have to cover oral care for adults. Dental care for children is required.

Some advocates pushed for a wider dental component in the bill, pointing to the larger impact of oral health on conditions like heart disease and diabetes.

Among the 172 million people under 65 who already have private health insurance, nearly three-quarters have dental insurance too, mostly through an employer, the CDC's National Center for Health Statistics said.

The survey found that among those with dental coverage, 33 percent had a comprehensive plan with dental coverage, while 26 percent had a stand-alone plan. Fourteen percent had both.

Among those with employer-sponsored care, just 20 percent lacked a dental plan.

The CDC's statistics unit analyzed data from its 2008 nationwide survey of 65,495 people under age 65.


Not surprisingly, the researchers found a direct link between income and access to care. The higher a person's income, the more likely they were to have dental coverage.

An estimated 90 million Americans get health insurance through Medicare and Medicaid, which do not cover dental care for adults. But researchers Barbara Bloom and Robin Cohen said they could only look at private sector "because of the limited or nonexistent public coverage for dental care."

It is not clear how the new healthcare law will affect the dental insurance industry. Like its health insurance counterpart, the sector lobbied against any government-run health program while seeking to boost funds for dental care under Medicaid.

Medicaid, which serves 45 million low-income people, pays for dental care for those under 21, but patients can have trouble finding dentists. A separate government program, the Children's Health Insurance Program, also provides limited dental care.

Older Americans can buy separate dental policies from insurers.

Health insurers that offer dental plans include Aetna Inc, Cigna Corp, UnitedHealth Group Inc, Humana Inc, and Assurant Inc, according to the Association for Health Insurance Plans, which represents about 80 percent of all U.S. dental insurance plans.

Most Blue Cross Blue Shield Association plans, MetLife, and Principal Financial Group Inc also offer dental coverage, the industry's lobby group said.

14 June 2010

N.Y. Law Limits Rise in Health Insurance Rates

NY Times

Gov. David A. Paterson has signed legislation that gives the state the power to block what it deems unreasonably high New York health insurance quotes increases for millions of New Yorkers.

The new law, which covers about three million people enrolled in small-employer or individually purchased plans, requires insurance companies to apply to the state Insurance Department before they can raise premiums. The state then has 60 days to determine whether the rates are justified.

The governor and consumer advocates said the law would slow down rampant premium increases, which they said had forced many small businesses and individual policyholders to drop their insurance, driving prices higher as costs were spread over a smaller pool of customers who tended to have high health care needs. New York has the highest average premiums for individually bought policies — $6,630 for single people and $13,296 for families in 2009, more than double the national average, according to industry figures.

Advocates said that the law could become a model for other states as they monitor rates in the new insurance exchanges, or organized marketplaces, required under the federal health care overhaul.

Over the last decade, “New York H.M.O.’s made outlandish profits,” Mark P. Scherzer, an insurance lawyer and consumer advocate, said on Wednesday. “What this is really going to do is save consumers money.”

The new law also requires insurance companies to spend 82 percent of premiums on medical care, rather than on administrative costs and profits, up from 75 percent for small-business policies and 80 percent for individual ones.

The law reinstates a system of prior approval that New York phased out between 1996 and 2000. Under the system in place for a decade, New York reviewed increases retroactively and issued refunds. The insurance industry contended that giving the state prior approval over rate increases would make the process more political.

Mark L. Wagar, president of Empire BlueCross BlueShield, said the legislation addressed that concern by giving automatic approval to a proposed rate increase if the state did not act within 60 days, and by requiring the state to give an actuarial basis for denying a rate increase.

The state does not similarly regulate most New York group health insurance plans, leaving it to employers to negotiate rates, an Insurance Department spokesman said.

FDA Warns Pfizer on Reporting Failures

The Wall Street Journal

The Food and Drug Administration warned Pfizer Inc. about its failure to properly follow the agency's rules on reporting adverse events involving products.

The agency sent Pfizer a letter dated May 26 that stemmed from an FDA inspection at Pfizer's New York headquarters from June 29 through Aug. 10, 2009. The letter outlined about a dozen violations of agency rules.

The warning letter is the second issued by the FDA. In April, Pfizer was warned about "significant violations" involving pediatric trials of its antipsychotic drug Geodon. Until the issues cited by the FDA in its warnings are resolved, the FDA can hold up approval of any products under review.

The May warning letter stemmed from last summer's inspection of Pfizer's headquarters. The FDA said the inspection was conducted to determine the company's compliance with postmarket adverse-event reporting rules, which require drug manufacturers to report potential problems it receives involving their products to the agency within a certain number of days.

The FDA said it found some reports of adverse events involving Lyrica and Lipitor that weren't reported to the agency until after the inspection found the reports.

One reporting requirement states that companies must report serious and unexpected adverse events to the agency within 15 calendar days after receiving such reports.

The agency said the company failed to submit some 15-day reports involving visual disturbances associated with the erectile dysfunction drug Viagra and downgraded some of the reported events to "nonserious without reasonable justification."

In a statement Wednesday, Pfizer said it would continue to work closely with the FDA "to address these issues to the agency's full satisfaction and to assure optimal surveillance and reporting of postmarketing adverse events."

Along with citing failures to properly follow adverse-event reporting rules, the FDA said the company failed to conduct an immediate investigation after receiving reports of prescription drug-sample thefts.

Pfizer spokeswoman Kristen Neese said, "It is important to note that the FDA letter does not call into question the safety profile of any Pfizer product."

The letter outlines longstanding problems with Pfizer's ability to properly report adverse events involving its products. The FDA said it issued inspection reports in 2004 and 2006 "for similar postmarking drug-adverse experience violations."

11 June 2010

Heart Attacks Down 24% in Decade

San Francisco Chronicle

A study of more than 46,000 Northern California Kaiser Permanente patients found a significant drop in heart attacks over a 10-year period, and more importantly, a major decrease in the most serious type of heart attacks - results that show that communitywide efforts to help people reduce their risk of heart disease seem to be working, doctors say.

The study, published in today's issue of the New England Journal of Medicine, showed that the heart attack rate among Kaiser patients fell 24 percent between 1999 and 2008 - the rate increased from 1999 to 2000, but declined every year after that. The types of heart attacks that do the most damage - known as ST-segment elevation heart attacks - fell 62 percent.

Over the same time period, more Kaiser patients lowered their blood pressure and cholesterol levels, and smoking rates decreased. The use of medications like beta-blockers and aspirin that are known to prevent heart disease increased. It would seem, authors of the study noted, that these preventive measures are working, perhaps even better than expected.

"Researchers keep trying to find more ways to treat heart attacks, but we need to focus just as much attention on things that we know work now, and doing those things on a large scale: adopting healthier lifestyles, stopping smoking, taking medications," say Garden City Heart Doctors.

A diverse study

Heart attack rates have been falling for more than 20 years in the United States with vastly improved preventive care and an understanding of the risk factors that lead to heart disease. But very few studies have looked at heart attack rates over the past 10 years, and the Kaiser study is one of the largest and most diverse in terms of age, race and sex.

The drop in heart attack rates is especially noteworthy, researchers said, because technology introduced in the last decade actually makes it easier for doctors to identify smaller, less serious heart attacks that may have gone undetected before. So even as doctors were able to catch more heart attacks, the rate continued to decline.

"If anything, the study underestimates the tremendous improvements that have been made to date," said Dr. Robert Pearl, executive director and CEO of the Permanente Medical Group.

In addition to the decrease in heart attack rates, the short-term death rate for heart attack victims improved. About 10.5 percent of patients who suffered a heart attack in 1999 died within a month, compared with 7.8 percent in 2008.

Looking at all heart attacks, the percentage of patients with the most serious types fell from 47 percent in 1999 to 23 percent in 2008. Part of that shift was due to doctors' ability to detect more of the less severe heart attacks, but part was due to a decline in the most severe heart attacks.

The more severe ST-segment elevation heart attacks - the name refers to a section of the waves produced by an electrocardiogram - occur when plaque builds up and ruptures, leading to a thick clot forming in a major artery and blocking blood supply. People with these heart attacks must have surgery immediately to unblock the artery.

In non-ST-segment elevation heart attacks, a less stable clot forms and blood is still able to move through the artery, although slowly. These patients can be treated with drugs that break up clots and thin the blood, according to Northville Heart Doctors.

A wake-up call

These smaller heart attacks are, in a way, wake-up calls to patients that they need to make serious changes to prevent a more severe heart attack in the near future, said Southgate Heart Doctors.

Researchers weren't surprised to see the overall drop in heart attack rates, but didn't expect to see the rate of very serious heart attacks decline so much.

That was really good news, because it suggests that the prevention things we're doing are really working, especially in terms of these events that really kill people. It's hard for people to see on a personal level what preventative therapies are doing for them. By looking at the population, this really demonstrates that we're actually making headway.

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California Nurses Rally for Higher Staffing Levels

Mercury News

Nurses at University of California hospitals around the state are rallying to demand a new contract with increased staffing levels.

Thursday's rallies come after a San Francisco judge barred the 11,000 nurses from staging a one-day strike for at least two weeks. The judge agreed with UC officials that a strike would pose a health risk to patients although he did agree to consider the issue further at a June 18 hearing.

The nurses and UC officials are at odds over salaries and staffing levels, as they begin contract discussions. Nurses say staffing levels often fall below state-mandated levels during breaks or shift changes.

UC officials say they are complying with state staffing requirements.

The rallies are being held at UC hospitals in Davis, Los Angeles, San Francisco, San Diego, Irvine and Santa Monica.

10 June 2010

Illinois Mosquitoes Test Postive for West Nile Virus


SHAWNEETOWN, Ill. -- Mosquitoes in southern Illinois' Gallatin (GAL'-uht'n) County are the first in the state to test positive for West Nile virus this year.

The Illinois Department of Public Health says the Egyptian Health Department collected the positive mosquito sample on June 3 in Shawneetown.

Birds have tested positive for West Nile so far this year in seven counties across the state.

Public health director Damon Arnold says the positive samples are a reminder to people to protect themselves against mosquito bites.

West Nile is transmitted through being bitten by an infected mosquito or eating an infected bird.

There were five human cases of West Nile virus reported in Illinois last year, down from a high of 252 cases in 2005.

08 June 2010

San Francisco Area Seeing Rise in Whooping Cough

San Francisco Chronicle

The Bay Area is in the middle of a whooping cough outbreak, with six times as many cases so far this year as last year, and public health officials are encouraging new parents to get vaccinated and avoid large crowds to protect their infants.

The entire state is seeing large increases in whooping cough, which is the familiar name for pertussis. So far five infants - all of them under 4 months old - have died in California, and all of them caught the disease from their mother or another caregiver.

None of the deaths have been in Northern California, but the Bay Area had 173 cases of whooping cough between January and the end of May, compared with 29 cases in the same period last year, according to the state public health department. Kaiser Permanente, the largest health care provider in the Bay Area, has seen 17 times more cases of pertussis in Northern California so far this year than last year.

"We would like to see everybody get immunized against pertussis - adolescents, adults, everyone. It's especially important for those around newborn infants," said Dr. John Talarico, chief of the immunization branch for the state public health department.

Whooping cough, which gets its name from the noise children make when they gasp for breath between violent coughs, is a respiratory infection that can be deadly in babies. It is usually just an annoying illness in older children and adults, although it can turn into bronchitis or other lung infections.
Natural cycle

The recent rise in whooping cough is probably due to the cyclical nature of an infectious disease: A large group of people gets sick and experiences a short period of immunity, and five or so years later, enough people have lost their immunity that the disease is able to spread freely again.

Pertussis was once thought to be on its way toward disappearing, like many once-widespread diseases that are now prevented with vaccines. But the whooping cough vaccine doesn't provide lifelong protection.

Babies start getting vaccinated at age 2 months and are considered fully protected by the time they enter kindergarten, but children probably lose their immunization by high school. Almost all adults are susceptible to the disease - and in fact, unprotected adults are "the reservoir" of infection that can spread to vulnerable babies, said Dr. Stephen Parodi, chief of infectious disease for Kaiser Permanente Northern California.

"We traditionally thought of pertussis as a children's disease, and that's who's been vaccinated in the past," Parodi said. "By the time we're young adults, we basically don't have immunity. That puts our young children at risk for getting exposed to it."

A vaccine for adults and older children became available in 2005 - it's known as the Tdap, and combines a pertussis vaccine with the tetanus booster shot adults should get every 10 years.

California public health officials are pushing programs to vaccinate all parents who have a baby. Vaccinations typically cost $67 in San Francisco. However, a coupon offering a discounted pertussis vaccination is given to anyone who picks up a birth certificate for a new baby.
Avoid crowds

Parents with newborns also might want to avoid large crowds for at least the first few months during the whooping cough outbreak, said Kathy Harriman, an epidemiologist with the state's public health immunization branch.

"It's probably not the greatest idea to take a new infant out amongst crowds, where you can't control who's around your infant, and people like to come up and take a look," Harriman said.

Doctors also stressed that parents of newborns check in with a pediatrician if a baby shows even mild symptoms of whooping cough, which resemble cold symptoms. The disease is easily treated with antibiotics, but by the time babies develop the obvious "whooping" noise in their cough, they are often very ill already.

"Infants who are infected initially don't look really sick," Harriman said. "They don't have a fever, they might have a runny nose, their cough might not be that noticeable. With a really young infant, I would err on the side of caution."
Symptoms of whooping cough

-- Initially, symptoms are similar to the common cold, and include runny nose, sneezing, red and watery eyes, and a dry cough.

-- After a week or two, severe coughing attacks may occur. Some individuals may develop a persistent hacking cough. For others, the coughing may be serious enough that patients bring up thick phlegm, vomit, turn red or blue in the face and become extremely fatigued. This is when the high-pitched "whoop" sound that defines the disease may become apparent.

-- Parents with infants should consult their pediatrician if their baby develops even mild cold symptoms in the middle of a whooping cough outbreak.
Whooping cough outbreak

California, and the Bay Area in particular, has seen a dramatic increase in whooping cough cases this year. Here are the statistics through May 31 compared with the same period in 2009:

California: 190 cases, no deaths in 2009; 584 cases, five deaths in 2010

Bay Area: 29 cases in 2009; 173 cases in 2010 (no deaths)

San Francisco had 20 confirmed or suspected cases of pertussis in all of 2009; it had 15 cases by May 27 this year. Alameda County had 33 cases in all of 2009 and 26 cases through May of this year.

Study: Avastin Keeps Ovarian Cancer in Check

LA Times

In a study of 1,873 women with untreated ovarian cancer, Avastin extended progression-free survival by 39% compared with standard chemotherapy alone.

The cancer drug Avastin extends progression-free survival by 39% in ovarian cancer patients, a significant improvement in a cancer that has proved extremely difficult to treat.

Some oncologists are already using Avastin — which is widely and successfully used for lung, colon and breast tumors — to treat ovarian cancer that has recurred, but such use has never been formally studied. The new study, reported Sunday at a Chicago meeting of the American Society of Clinical Oncology, is also the first to use the drug as first-line therapy for ovarian cancer.

Ovarian cancer is the eighth most common cancer among American women, striking an estimated 22,000 women each year, and the fifth most deadly, killing 15,000. Conventional chemotherapy uses the powerful drugs carboplatin and paclitaxel, which can have severe side effects.

Avastin, in contrast, is targeted at a naturally occurring protein called vascular endothelial growth factor, which is overproduced in many cancers and stimulates the growth of new blood vessels that nourish the tumor. That targeting means it has fewer potential side effects and thus represents an improvement in therapy for ovarian cancer, said Dr. Robert A. Burger of the Fox Chase Cancer Center in Philadelphia, who led the new study.

Burger and his colleagues studied 1,873 women with previously untreated ovarian cancer that had metastasized to the stomach and other organs. A third of them received conventional chemotherapy plus Avastin at the time of chemotherapy and in maintenance doses throughout the follow-up; a third received conventional chemotherapy plus Avastin and maintenance doses of a placebo; and a third received only conventional chemotherapy plus placebos.

Burger reported that during the 17 months of follow-up, conventional chemotherapy held the women's tumors in check for 10.3 months before they started progressing again, while chemotherapy plus Avastin and maintenance doses increased that period to 14.1 months.

Using Avastin during the initial chemotherapy period without maintenance doses provided no statistically significant increase in progression-free survival. The study is ongoing, so the researchers do not yet know how the drug affected overall survival.

The principal side effects of the treatment were increases in blood pressure and gastrointestinal problems. The women also had somewhat more pain than those taking placebo. All are similar to side effects observed in treating other types of cancer.

The drug was developed by South San Francisco-based Genentech, a subsidiary of Swiss pharmaceutical giant Roche. Genentech said it would apply to the Food and Drug Administration for permission to market the drug for use against ovarian cancer. Such approval is normally required before insurance companies will pay for treatment.

The study was funded by Roche, but was organized and overseen by the National Cancer Institute.