Susan Heavey, Reuters: September 23, 2009

WASHINGTON (Reuters) – The U.S. Food and Drug Administration took its first steps to rein in the tobacco industry on Tuesday, implementing a ban on candy, clove and other flavored cigarettes.

The move, required by a law passed earlier this year giving the FDA greater power over tobacco products, aims to help prevent children and teenagers from smoking.

“Candy and fruit flavored cigarettes are a gateway for many children and young adults to become regular tobacco users,” Dr. Lawrence Deyton, head of the FDA’s Center for Tobacco Products, told reporters in a conference call.

In June, President Barack Obama signed legislation allowing the FDA to oversee the manufacturing and marketing of cigarettes and other tobacco products, including regulating ingredients and limiting advertising. The agency must also approve any new tobacco products.

Still, the bill excludes any immediate action on menthol, or mint, flavored cigarettes that are used by as many as 12 million Americans, including most African-American smokers. Lawmakers instead called on the FDA to study the issue.

It is not immediately clear how effective the ban will be or what impact it will have on smoking habits.

“Although it will take time for it to have a 100 percent effect … it will have a dramatic effect on children and young women who are most likely to smoke these products,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Children who already smoke may switch to regular cigarettes, but many will be reluctant try smoking if products don’t taste good, she said. “I think it does make it harder for companies to try to get away with anything,” she added.

The ban in unlikely to affect U.S. tobacco companies such as Altria Group Inc’s Philip Morris unit and Lorillard Inc’s Lorillard Tobacco Co, which do not make flavored cigarettes.

But some advocates have already expressed concern that smaller companies will simply shift their attention to cigars, snuff and other tobacco products not covered by Tuesday’s ban.

The Campaign for Tobacco-Free Kids, which supported the FDA’s new oversight, said the nation’s top distributor of clove-flavored cigarettes, California-based Kretek International Inc., now sells clove cigars that look and taste like its clove cigarettes.

Representatives for Kretek, which imports most of its products, could not be immediately reached. Star Scientific and other companies also make dissolvable smokeless tobacco products in various flavors.

FDA’s Deyton said the agency would discuss other flavored products.

The FDA posted information about the ban on its website here

(Editing by Steve Orlofsky)

Marie McCullough, Philadelphia Inquirer: September 10, 2009

Government advisers yesterday recommended federal approval of Cervarix, the GlaxoSmithKline cervical cancer vaccine, after reviewing studies showing it is significantly more effective than Gardasil, the rival vaccine made by Merck & Co.

But Merck’s product, which has had a three-year head start in the U.S. market, got another boost yesterday when the committee urged the U.S. Food and Drug Administration to expand its approval for prevention of genital warts to a new market: males ages 9 to 26.

Both vaccines prevent infection with two types of human papillomavirus that cause about 80 percent of cervical cancers. Only Gardasil also protects against two types of HPV that cause 90 percent of genital warts.

While the FDA is not required to follow advisers’ recommendations, it usually does.

The latest endorsements will likely sharpen a rivalry with much local resonance. London-based GlaxoSmithKline P.L.C. directed much development of its vaccine at offices in the Philadelphia region, while Gardasil is made in and marketed from West Point, Montgomery County, home to Merck’s vaccine division.

The new studies also come as enthusiasm for HPV vaccination – hailed as a public health breakthrough three years ago – seems to be cooling amid persistent concerns about safety and questions about how long the vaccine protection will last. Gardasil’s sales slid 5 percent last year to $1.4 billion.

GlaxoSmithKline had submitted Cervarix clinical trial data and sought approval more than two years ago, but the FDA asked for more information. The agency was concerned that the vaccine’s novel “adjuvant” – a chemical that heightens immune response to the vaccine – might be triggering rare autoimmune diseases such as optic neuritis or Guillian-Barre syndrome.

In March 2009, GlaxoSmithKline submitted data from the single largest trial of a cervical cancer vaccine to date, with nearly 30,000 participants receiving Cervarix, some for as long as 6.4 years. The data showed that autoimmune diseases were not more common among vaccinated women than those in a control group.

GlaxoSmithKline also addressed another FDA concern – about spontaneous abortion. Although women were given a pregnancy test and told they should not be vaccinated if they were pregnant, about 7,200 got pregnant around the time of vaccination.

More spontaneous abortions occurred in the Cervarix group than the control group – 13 percent compared with about 9 percent – but this could have been by chance.

“I think we have to remember that both groups had lower spontaneous abortion rates than” normally occur in women in general, noted committee member Kenneth Noller, an obstetrician-gynecologist at Tufts University School of Medicine in Boston.

Like Gardasil, Cervarix is too new for scientists to know whether protection against HPV will last indefinitely. But Cervarix effectiveness data were clearly superior to those of Gardasil.

Like Gardasil, Cervarix was more than 90 percent effective at preventing precancerous lesions caused by the two “high-risk” HPV strains in women who had not been exposed to the virus before immunization. But Cervarix also was 75 percent effective at protecting against three cancer-causing HPV types that are not part of the vaccine, while Gardasil is only about 50 percent effective against one nonvaccine type.

In addition, blood tests showed that the concentration of virus-fighting antibodies was two to three times higher with Cervarix than with Gardasil – and remained high for 6.4 years.

By contrast, antibody levels fell back to natural pre-vaccination concentrations after two to three years in both males and females who had the Gardasil shots.

Merck officials say ongoing studies show that the vaccine remains effective in warding off warts and precancerous lesions despite the fall-off in antibodies. “But I would not tell you we’ll never need to give a booster shot” to Gardasil vaccines, Gregg Sylvester, Merck director of medical affairs for adult and adolescent vaccines, said in an interview after the hearing.

Others, like researcher Diana Zuckerman, say Gardasil is increasingly unappealing, especially considering that women have to continue to get regular Pap smears to screen for cervical cancer. Zuckerman is president of the National Research Center for Women and Families and a fellow at the University of Pennsylvania’s Center for Bioethics.

“Our center was excited when Gardasil was first approved, but the more we learned about how limited the data were, the more concerned we became,” she told the committee. “This is a very expensive vaccine – costing more than $400 – and we need to know how long it lasts. That’s true for women, and it’s even more true for men since the benefits are more limited. The boys of America are not facing an epidemic of genital warts.”[…]

Read the original article here.

Matthew Perrone, Associated Press: September 9, 2009

Printed in the Associated Press, The Houston Chronicle, San Francisco Examiner, and other newspapers across the country

WASHINGTON — Drugmaker Merck likely will face U.S. competition for its vaccine Gardasil, after federal experts recommended rival GlaxoSmithKline’s Cervarix also be approved to prevent the virus that causes most cervical cancers.

The FDA’s panel of vaccine experts voted overwhelmingly Wednesday that Cervarix appears safe and effective for girls and women ages 10 to 25. If the FDA follows the group’s advice as it usually does, Glaxo would begin competing against Merck’s Gardasil, which has controlled the U.S. market since 2006.

But Merck won its own small victory at the meeting, as the same panel recommended Gardasil be expanded to prevent genital warts in boys, a new use for a vaccine that already posts sales of more than $1 billion.

While panelists favored the expanded approval, they questioned how widely the vaccine would be used, since genital warts are not a serious medical condition.

“Genital warts are a nuisance, they’re ugly and can sometimes be stigmatizing,” said Dr. Kenneth Noller, of Tufts University. “But in men and women with healthy immune systems they go away by themselves.”

The human papilloma virus, or HPV, infects about 6 million people in the U.S. each year, and is mainly spread through sexual contact. It usually causes no symptoms and goes away within two years, though rare cases can develop into warts and cancer in both men and women.

Last year nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all cancer related deaths.

London-based drugmaker Glaxo already has won approval for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data.

Panelists said newer studies suggest the vaccine is safe, but they recommended follow-up studies to monitor miscarriages and inflammatory-muscular problems reported by a small number of patients.

The group said it was unlikely those problems were related to the vaccine, but said the issues should still appear on product labeling.

“I think this could be marketed with the usual caveat that it’s not to be used during pregnancy,” Noller said.

Even if the FDA grants approval, Glaxo will face an uphill battle against competitor Merck. Besides an established brand in the U.S., Gardasil also boasts an extra degree of protection against sexually transmitted diseases.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck’s vaccine also defends against two other HPV types that cause 90 per cent of genital warts, something Cervarix does not target.

Leerink Swan analyst Seamus Fernandez estimates Cervarix will eventually make up 25-30 percent of the total market for HPV-blocking vaccines. Cervarix global sales were $231 million last year.

In separate votes Wednesday, FDA’s panel ruled that Gardasil successfully prevents genital warts in boys and men ages 9 to 26.

While an approval decision from the FDA could theoretically double the market opportunity for Gardasil, analysts don’t expect much use among males.

“If it’s not preventing something serious like cervical cancer and there are questions about safety, I think a parents’ acceptance of the vaccine in young boys might be less urgent than for their girls,” Fernandez said in an interview last week.

Gardasil became an early success story for Merck after its launch, with sales growing to over $1.4 billion last year.

But momentum has slowed amid questions about the longevity of the vaccine’s effect and its cost effectiveness, considering its price tag of nearly $400.

Merck has tracked HPV immunity out to five years in women, and just three years in boys and men. Public health advocates argued Gardasil should not be approved for boys without evidence of its long-term effectiveness.

“The boys of America are not facing an epidemic of genital warts,” said Diana Zuckerman, of the National Research Center for Women and Families in Washington, during a public comment period. “We have time to wait for better data before approval.”

Dr. Richard Haupt, Whitehouse Station, N.J.-based Merck’s head researcher for Gardasil, said the company plans long term studies to track the vaccine’s effectiveness over time.

“Our long term evaluations will look at immune response, but more importantly they will look at disease prevention over time,” said Haupt.

Matthew Perrone, Associated Press: September 4, 2009

WASHINGTON (AP) — Federal regulators said Friday that a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck’s blockbuster Gardasil, which has controlled the U.S. market for three years.

In documents posted online, the Food and Drug Administration said Cervarix _ Glaxo’s vaccine against human papilloma virus or HPV _ successfully blocked the two leading strains of the virus nearly 93 percent of the time.

But even as the British drugmaker moves closer to competing in the U.S., Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time.

The agency will ask a panel of vaccine experts next week to weigh in on both vaccines. The FDA is not required to follow the group’s advice, though it usually does.

While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal.

Genital warts caused by HPV usually clear up by themselves, and the cancers caused by the virus are extremely rare in men.

“If it’s not preventing something serious like cervical cancer and there are questions about safety, I think parents’ acceptance of the vaccine in young boys might be less urgent than for their girls,” said Fernandez.

Glaxo has won a number of government contracts for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine. Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with an alternate treatment.

The FDA said Friday that outside experts have now determined Cervarix did not cause those problems.

“The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link,” the agency said in its review.

FDA reviewers also noted a slightly higher rate of miscarriages in women taking Cervarix, but said “the data do not establish a causal relationship.”

Glaxo wants its vaccine approved for girls and women ages 10 to 25. The FDA is expected to make a decision on the vaccine later this year, but analysts say London-based Glaxo may still have trouble making inroads into the U.S. market.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck’s vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target.

The most common side effects with both vaccines were pain and swelling at the injection site.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

But sales have been slowing amid questions about the longevity of the vaccine’s effect and its price tag of nearly $400. In the most recent quarter, Gardasil sales fell to $268 million, down 18 percent from the prior year period.

A government-funded study last year found that the HPV vaccine is cost-effective for young teens, but not for women in their 20s. And labeling for the vaccine notes that the “duration of protection of Gardasil has not been established.” Company trials have only tracked immunity out to five years after receiving the three-injection regimen.

Whitehouse, N.J.-based Merck will make the case on Sept. 9 for approving the vaccine for boys and men ages 9 to 26.

But the company is expected to face push-back next week from public health activists who already question the vaccine’s benefit for its main target market: women.

Some argue that $375 is too much to pay to protect against genital warts and diseases like penile cancer, which affect less than 1 percent of American men.

“It’s a lot of money for a little bit of extra protection from diseases that are not a big problem in this country,” said Dr. Diana Zuckerman of the National Research Center for Women and Families in Washington. Zuckerman, who is scheduled to speak at next week’s meeting, says the additional use will do more to boost Merck’s sales than control HPV-related diseases.

“This is great for the company. The more people use this vaccine, the more money the company makes,” Zuckerman said.

Cancer of the penis and anus are extremely rare, with less than 2,000 cases reported annually. But Merck argues the cost of treating those cases is often underestimated.[…]

Jim Abrams, Associated Press: July 30, 2008

WASHINGTON (AP) – Dismayed by reports of millions of tainted toys, the House neared a vote Wednesday to ban lead and other dangerous chemicals from toys and other products that could wind up in kids’ mouths.

The legislation also would toughen rules for testing children’s products and take steps to give more muscle to the Consumer Product Safety Commission, which was criticized last year for its feeble handling of a flood of goods from China deemed hazardous to children.

“Congress is about to sign off on the most comprehensive product safety legislation in decades,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families.

The bill, a product of House-Senate negotiations, would ban lead in products for children 12 or younger, and would ban – either permanently or pending further study – six types of phthalates, which are chemicals that are found in plastics and suspected of posing health risks.

House passage would send the measure to the Senate, which could approve it before Congress leaves for its August recess at the end of this week. The White House has voiced opposition to parts of the legislation but has not threatened a veto.

The bill would require third-party testing for many children’s products, a key change in monitoring practices following a year in which 45 million toys and children’s products – 30 million from China – were recalled.

Those included lead-contaminated children’s jewelry, “Spider-Man 3” flashing rings and Halloween pails.

“Third-party testing is a centerpiece of the new law” and a victory for consumers, said Ed Mierzwinski, consumer program director of U.S. PIRG, a grass-roots environmental organization.

The bill would double the budget of the Consumer Product Safety Commission, to $136 million by 2014, and give it new authority to impose civil penalties on violators. The CPSC was founded in 1973 with a staff of about 800. It now employs about half that number, while imports have vastly increased.

It also would boost whistleblower protections to encourage people to report hazards to the CPSC and would direct the agency to set up a database where consumers, government agencies, child care providers or doctors could report incidents of injury, illness, death or risk related to products.

One of the more controversial provisions is the ban on six types of phthalates, chemicals used in a wide range of products, including toys, to make vinyl soft and flexible. Tests on rats have found links to possible reproductive system problems for males and the onset of early puberty for females, and the European Union has banned the six.

Ami Gadhia of Consumers Union said infants are exposed to phthalates through toys, teethers and health care products. While there is no conclusive evidence that the chemical causes health problems in humans, she said a recent study found that mothers reported use of infant lotion, infant powder and shampoo was significantly associated with phthalate urinary concentrations.

But phthalates, said Sharon Kneiss of the American Chemistry Council, “are an important part of our everyday lives. There is no scientific basis for Congress to restrict phthalates from toys and children’s products.”

Under the new third-party testing regimen, a standards organization would set up and run a mandatory protocol that testing labs would have to meet to certify a product. No covered children’s product or toy could be imported without a certification mark. The CPSC has authority to approve and audit the certifications.

The negotiators also resolved to make more products now covered by voluntary industry standards subject to mandatory standards. That step added several potential toy hazards, including goods containing small magnets that were included in products recalled last year, subject to third-party testing requirements.

Among other provisions, the bill requires the CPSC to adopt safety standards on all-terrain vehicles and close a loophole where cribs sold secondhand were not subject to the same standards as new cribs.

The bill is H.R. 4040

Matthew Perrone, Associate Press: July 22, 2009