FDA

SA Developed Melanoma Drug Now Seen Effective in Fighting Lung Cancer

Source: www.woai.com
Author: News Radio 1200 WOAI Staff

 

1229_1264794779Keytruda, a cancer drug developed largely at San Antonio’s START Center, has already proven to be effective in treating advanced melanoma to the point that it is the major part of former President Jimmy Carter’s treatment.  Now, News Radio 1200 WOAI reports Keytruda has been given ‘fast track’ approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States.

Dr. Amita Patnaik, a researcher and oncologist at START who helped develop the drug, says the impact of Keytruda on lung cancer patients has been amazing.

“Close to 40% of those patients will receive a response,” she said.  “And of those patients who receive a response, about 80% of those patients will have a long term response.”

The life saving potential of Keytruda in fighting non small cell lung tumors is obvious.  An estimated 221,000 Americans are diagnosed with lung cancer each year, and 158,000 die of the disease annually.

Dr. Patnaik says Keytruda is becoming the most successful of what are known as ‘targeted therapies,’ drugs which trigger the body to take action to fight the cancer.  She says both melanoma and lung cancer work essentially the same way to undermine the body’s defenses.

“The commonality between melanoma and lung cancer is there is a supressive effect of the cancer on the immune system.”

She says Keytruda essentially overrides that supressive effect, prompting the body to restart its natural immune defenses and fight the cancer.

That means the treatment takes place without chemotherapy.

“Thus avoiding some of the toxicities associated with chemotherapy including hair loss, fatigue, a drop in counts, nausea and vomiting, and the spectrum of negative side effects you get with chemo.”

Dr. Patnaik says several other types of cancers work the same way, ‘turning off’ the body’s natural immune systems, and she says there are indications that Keytruda will work for those cancers as well.

“Keytruda is showing activity in about ten or more other cancers, including liver cancer, head and neck cancer, and in a rare form of breast cancer.”

The FDA granted Keytruda ‘breakthrough therapy designation’ because of demonstrated preliminary clinical evidence that the drug may ‘offer a substantial improvement over available therapies.’

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

October, 2015|Oral Cancer News|

The Cost of Cancer Drugs

Source: www.cbsnew.com
Author: Lesley Stahl
 

The following is a script of “The Cost of Cancer Drugs” which aired on October 5, 2014, and was rebroadcast on June 21, 2015. Lesley Stahl is the correspondent. Richard Bonin, producer.

Cancer is so pervasive that it touches virtually every family in this country. More than one out of three Americans will be diagnosed with some form of it in their lifetime. And as anyone who’s been through it knows, the shock and anxiety of the diagnosis is followed by a second jolt: the high price of cancer drugs.

They are so astronomical that a growing number of patients can’t afford their co-pay, the percentage of their drug bill they have to pay out-of-pocket. As we first reported in October, this has led to a revolt against the drug companies led by some of the most prominent cancer doctors in the country.

Dr. Leonard Saltz: We’re in a situation where a cancer diagnosis is one of the leading causes of personal bankruptcy.

Dr. Leonard Saltz is chief of gastrointestinal oncology at Memorial Sloan Kettering, one of the nation’s premier cancer centers, and he’s a leading expert on colon cancer.

Lesley Stahl: So, are you saying in effect, that we have to start treating the cost of these drugs almost like a side effect from cancer?

Dr. Leonard Saltz: I think that’s a fair way of looking at it. We’re starting to see the term “financial toxicity” being used in the literature. Individual patients are going into bankruptcy trying to deal with these prices.

Lesley Stahl: The general price for a new drug is what?

Dr. Leonard Saltz: They’re priced at well over $100,000 a year.

Lesley Stahl: Wow.

Dr. Leonard Saltz: And remember that many of these drugs, most of them, don’t replace everything else. They get added to it. And if you figure one drug costs $120,000 and the next drug’s not going to cost less, you’re at a quarter-million dollars in drug costs just to get started.

Lesley Stahl: I mean, you’re dealing with people who are desperate.

Dr. Leonard Saltz: I do worry that people’s fear and anxiety are being taken advantage of. And yes, it costs money to develop these drugs, but I do think the price is too high.

The drug companies say it costs over a billion dollars to bring a new drug to market, so the prices reflect the cost of innovation.

The companies do provide financial assistance to some patients, but most people aren’t eligible. So many in the middle class struggle to meet the cost of their co-payments. Sometimes they take half-doses of the drug to save money. Or delay getting their prescriptions refilled.

Dr. Saltz’s battle against the cost of cancer drugs started in 2012 when the FDA approved Zaltrap for treating advanced colon cancer. Saltz compared the clinical trial results of Zaltrap to those of another drug already on the market, Avastin. He says both target the same patient population, work essentially in the same way. And, when given as part of chemotherapy, deliver the identical result: extending median survival by 1.4 months, or 42 days.

Dr. Leonard Saltz: They looked to be about the same. To me, it looked like a Coke and Pepsi sort of thing.

Then Saltz, as head of the hospital’s pharmacy committee, discovered how much it would cost: roughly $11,000 per month, more than twice that of Avastin.

Lesley Stahl: So $5,000 versus $11,000. That’s quite a jump. Did it have fewer side effects? Was it less toxic? Did it have…

Dr. Leonard Saltz: No…

Lesley Stahl: …Something that would have explained this double price?

Dr. Leonard Saltz: If anything, it looked like there might be a little more toxicity in the Zaltrap study.

He contacted Dr. Peter Bach, Sloan Kettering’s in-house expert on cancer drug prices.

Lesley Stahl: So Zaltrap. One day your phone rings and it’s Dr. Saltz. Do you remember what he said?

Dr. Peter Bach: He said, “Peter, I think we’re not going to include a new cancer drug because it costs too much.”

Lesley Stahl: Had you ever heard a line like that before?

Dr. Peter Bach: No. My response was, “I’ll be right down.”

Lesley Stahl: You ran down.

Dr. Peter Bach: I think I took the elevator. But yes, exactly.

Bach determined that since patients would have to take Zaltrap for several months, the price tag for 42 days of extra life would run to nearly $60,000. What they then decided to do was unprecedented: reject a drug just because of its price.

Dr. Peter Bach: We did it for one reason. Because we need to take into account the financial consequences of the decisions that we make for our patients. Patients in Medicare would pay more than $2,000 a month themselves, out-of-pocket, for Zaltrap. And that that was the same as the typical income every month for a patient in Medicare.

Lesley Stahl: The co-pay.

Dr. Peter Bach: Right. 20 percent. Taking money from their children’s inheritance, from the money they’ve saved. We couldn’t in good conscience say, “We’re going to prescribe this more expensive drug.”

And then they trumpeted their decision in the New York Times. Blasting what they called “runaway cancer drug prices,” it was a shot across the bow of the pharmaceutical industry and Congress for passing laws that Bach says allow the drug companies to charge whatever they want for cancer medications.

Dr. Peter Bach: Medicare has to pay exactly what the drug company charges. Whatever that number is.

Lesley Stahl: Wait a minute, this is a law?

Dr. Peter Bach: Yes.

Lesley Stahl: And there’s no negotiating whatsoever with Medicare?

Dr. Peter Bach: No.

Another reason drug prices are so expensive is that according to an independent study, the single biggest source of income for private practice oncologists is the commission they make from cancer drugs. They’re the ones who buy them wholesale from the pharmaceutical companies, and sell them retail to their patients. The mark-up for Medicare patients is guaranteed by law: the average in the case of Zaltrap was six percent.

Dr. Leonard Saltz: What that does is create a very substantial incentive to use a more expensive drug, because if you’re getting six percent of $10, that’s nothing. If you’re getting six percent of $10,000 that starts to add up. So now you have a real conflict of interest.

But it all starts with the drug companies setting the price.

Dr. Peter Bach: We have a pricing system for drugs which is completely dictated by the people who are making the drugs.

Lesley Stahl: How do you think they’re deciding the price?

Dr. Peter Bach: It’s corporate chutzpah.

Lesley Stahl: We’ll just raise the price, period.

Dr. Peter Bach: Just a question of how brave they are and how little they want to end up in the New York Times or on 60 Minutes.

That’s because media exposure, he says, works. Right after their editorial was published, the drug’s manufacturer, Sanofi, cut the price of Zaltrap by more than half.

Dr. Peter Bach: It was a shocking event. Because it was irrefutable evidence that the price was a fiction. All of those arguments that we’ve heard for decades, “We have to charge the price we charge. We have to recoup our money. We’re good for society. Trust us. We’ll set the right price.” One op-ed in the New York Times from one hospital and they said, “Oh, okay, we’ll charge a different price.” It was like we were in a Turkish bazaar.

Lesley Stahl: What do you mean?

Dr. Peter Bach: They said, “This carpet is $500” and you say, “I’ll give you $100.” And the guy says, “Okay.” They set it up to make it highly profitable for doctors to go for Zaltrap instead of Avastin. It was crazy!

But he says it got even crazier when Sanofi explained the way they were changing the price.

Dr. Peter Bach: They lowered it in a way that doctors could get the drug for less. But patients were still paying as if it was high-priced.

Lesley Stahl: Oh, come on.

Dr. Peter Bach: They said to the doctor, “Buy Zaltrap from us for $11,000 and we’ll send you a check for $6,000.” Then you give it to your patient and you get to bill the patient’s insurance company as if it cost $11,000. So it made it extremely profitable for the doctors. They could basically double their money if they use Zaltrap.

“High cancer drug prices are harming patients because either you come up with the money, or you die.”

All this is accepted industry practice. After about six months, once Medicare and private insurers became aware of the doctor’s discount, the price was cut in half for everyone.

John Castellani: The drug companies have to put a price on a medicine that reflects the cost of developing them, which is very expensive and takes a long period of time, and the value that it can provide.

John Castellani is president and CEO of PhRMA, the drug industry’s trade and lobbying group in Washington.

Lesley Stahl: If you are taking a drug that’s no better than another drug already on the market and charging twice as much, and everybody thought the original drug was too much…

John Castellani: We don’t set the prices on what the patient pays. What a patient pays is determined by his or her insurance.

Lesley Stahl: Are you saying that the pharmaceutical company’s not to blame for how much the patient is paying? You’re saying it’s the insurance company?

John Castellani: I’m saying the insurance model makes the medicine seem artificially expensive for the patient.

He’s talking about the high co-pay for cancer drugs. If you’re on Medicare, you pay 20 percent.

Lesley Stahl: Twenty percent of $11,000 a month is a heck of a lot more than 20 percent of $5,000 a month.

John Castellani: But why should it be 20 percent instead of five percent?

Lesley Stahl: Why should it be $11,000 a month?

John Castellani: Because the cost of developing these therapies is so expensive.

Lesley Stahl: Then why did Sanofi cut it in half when they got some bad publicity?

John Castellani: I can’t respond to a specific company.

Sanofi declined our request for an interview, but said in this email that they lowered the price of Zaltrap after listening “to early feedback from the oncology community and … To ensure affordable choices for patients…”

Dr. Hagop Kantarjian: High cancer drug prices are harming patients because either you come up with the money, or you die.

Hagop Kantarjian chairs the department of leukemia at MD Anderson in Houston. Inspired by the doctors at Sloan Kettering, he enlisted 119 of the world’s leading leukemia specialists to co-sign this article about the high price of drugs that don’t just add a few weeks of life, but actually add years, like Gleevec.

It treats CML, one of the most common types of blood cancer that used to be a death sentence, but with Gleevec most patients survive for 10 years or more.

Dr. Hagop Kantarjian: This is probably the best drug we ever developed in cancer.

Lesley Stahl: In all cancers?

Dr. Hagop Kantarjian: So far. And that shows the dilemma, because here you have a drug that makes people live their normal life. But in order to live normally, they are enslaved by the cost of the drug. They have to pay every year.

Lesley Stahl: You have to stay on it. You have to keep taking it.

Dr. Hagop Kantarjian: You have to stay on it indefinitely.

Gleevec is the top selling drug for industry giant Novartis, bringing in more than $4 billion a year in sales. $35 billion since the drug came to market. There are now several other drugs like it. So, you’d think with the competition, the price of Gleevec would have come down.

Dr. Hagop Kantarjian: And yet, the price of the drug tripled from $28,000 a year in 2001 to $92,000 a year in 2012.

Lesley Stahl: Are you saying that the drug companies are raising the prices on their older drugs.

Dr. Hagop Kantarjian: That’s correct.

Lesley Stahl: Not just the new ones. So you have a new drug that might come out at a $100,000, but they are also saying the old drugs have to come up to that price, too?

Dr. Hagop Kantarjian: Exactly. They are making prices unreasonable, unsustainable and, in my opinion, immoral.

When we asked Novartis why they tripled the price of Gleevec, they told us, “Gleevec has been a life-changing medicine … When setting the prices of our medicines we consider … the benefits they bring to patients … The price of existing treatments and the investments needed to continue to innovate…”

[Dr. Hagop Kantarjian: This is quite an expensive medication.]

Dr. Kantarjian says one thing that has to change is the law that prevents Medicare from negotiating for lower prices.

Dr. Hagop Kantarjian: This is unique to the United States. If you look anywhere in the world, there are negotiations. Either by the government or by different regulatory bodies to regulate the price of the drug. And this is why the prices are 50 percent to 80 percent lower anywhere in the world compared to the United States.

Lesley Stahl: Fifty percent to 80 percent?

Dr. Hagop Kantarjian: Fifty percent to 80 percent.

Lesley Stahl: The same drug?

Dr. Hagop Kantarjian: Same drug. American patients end up paying two to three times more for the same drug compared to Canadians or Europeans or Australians and others.

Lesley Stahl: Now, Novartis, which makes Gleevec, says that the price is fair because this is a miracle drug. It really works.

Dr. Hagop Kantarjian: The only drug that works is a drug that a patient can afford.

The challenge, Dr. Saltz at Sloan Kettering says, is knowing where to draw the line between how long a drug extends life and how much it costs.

Lesley Stahl: Where is that line?

Dr. Leonard Saltz: I don’t know where that line is, but we as a society have been unwilling to discuss this topic and, as a result, the only people that are setting the line are the people that are selling the drugs.

Since we first broadcast our story, President Obama asked Congress to change the law and allow Medicare to negotiate prices with drug manufacturers. Few believe, however, that Congress will let that happen anytime soon.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

 

FDA Advisory Committee hesitates to endorse message of safe smokeless tobacco

Source: www.medpagetoday.com
Author: Shannon Firth

An FDA advisory panel were reluctant to recommend a gentler warning label for one brand of smokeless tobacco products at a committee hearing on Friday.

snus

Swedish Match North America (SMNA), the first company to be considered for a modified risk tobacco designation by the FDA, is asking to replace a current label warning, “This product is not a safe alternative to cigarettes,” with this: “Warning: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

It also wants to drop warnings required for other smokeless tobacco products about oral cancers, tooth loss, and gum disease.

In a key vote, the eight-member FDA’s Tobacco Products Scientific Advisory Committee split 4-4 on whether the claim that snus offer a “substantially lower risk” claim relative to cigarettes is justified.

Many members said the health risks were lower for certain tobacco-related illnesses, but not for all health concerns. Those who disputed the claim argued that it could not be taken as a “global statement” — as there are known risks to pregnant women and uncertain risks for adolescents.

As for the proposed label change, the whole committee agreed that the sponsor’s statements would not suffice. Gary Giovino, PhD, chair of the department of Community Health and Health Behavior at the State University of New York at Buffalo, felt the statement was “dismissive of the health risks.” The word “but” in any sentence seems to negate the first half, he said.

Snus is a finely ground smokeless tobacco powder in a filter packet that is placed under the upper lip.

In his opening remarks on Thursday, Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said that in the past companies alone decided how to advertise their products — a practice which proved damaging to consumers’ health. “Now it’s the FDA who serves as the regulatory gatekeeper, standing between consumers and the companies seeking to make claims about their products.”

To meet the standards of a modified risk tobacco product, Zeller explained, “Applicants must not only demonstrate that the products, as actually used by consumers, will significantly reduce risks to individual users of those products; they must demonstrate that they will benefit the population as a whole – taking into account both users and non-users of tobacco products.”

In its application, Swedish Match has asked to revise the labels for 10 snus products. It would maintain its warning that smokeless tobacco is addictive.

Oral Safety Unproven
The committee was unmoved by the firm’s evidence related to gum disease and tooth loss and voted 8-0 against supporting a conclusion that snus products “do not pose a risk of gum diseases or tooth loss.”

Or as Thomas Novotny, MD, MPH, the graduate school of public health at the University of California San Diego State said, when explaining his vote, “It’s not causal relationships that we’re after, it’s perception of risk and the studies don’t rule that out.”

The committee’s vote was likely influenced by Scott Tomar, DMD, MPH, DrPH, of the department of Community Dentistry and Behavioral Science, at the University of Florida, who said that “advanced gingival recession can result in tooth loss.” One of the studies presented showed a relationship between gingival recession and snus use.

As to whether snus products also “do not pose risks of oral cancer” to consumers, the committee was split 3-3 with two abstentions.
“I think the data are tending towards no increased risk but I’m not quite ready to go there,” said Giovino, one of the abstainers.

Pebbles Fagan, PhD, MPH, associate professor and member of the Cancer Prevention and Control Program at the University of Hawaii, said that based on the absence of women in the larger cohort studies, she was not comfortable claiming that snus products posed no risk of oral cancer.

Can the ‘Swedish Experience’ Cross the Ocean?
Perhaps the most important questions the committee voted on was whether the proposed labeling change would help or harm consumers. Swedish Match threw the weight of its argument behind the “Swedish Experience,” a series of government, academic ,and industry studies showing a dramatic shift from cigarette smoking to snus in the mid-1990s. The firm argued that Swedish men reduced their risk of tobacco-related diseases.

But asked whether American tobacco users would likely follow suit — swapping cigarettes for snus — panel members were unconvinced.

Only one committee member said such a switch was likely, against six voting against and one abstention.

Richard O’Connor, PhD, associate professor of oncology at the Roswell Park Cancer Institute, in Buffalo New York, the lone panelist to agree that the experience in Sweden might translate to the U.S., said the data informed “a potential pattern in the U.S.”

Another subpopulation of obvious concern is adolescents. Timothy McAfee, PhD, MPH, director of the Office on Smoking and Health at the CDC, cited animals studies on tobacco addiction that showed “deleterious effects on adolescent brain development.”

On the plus side for Swedish Match, the majority of the committee felt it unlikely that nonusers of tobacco would pick up the snus habit, although three committee members abstained from this question because they did not believe there was enough data to support such a scenario.

Lars-Erik Rutqvist, the senior vice president of scientific affairs at Swedish Match said the company was pleased with the discussion at the hearing. “On the whole they seemed to accept the fact that there is a considerable risk reduction in our products and of course that’s very important. It’s part of the definition of a modified risk product.” Rutqvist added that he would expect to continue discussions with the FDA while awaiting their decision this summer.

“I look forward to the path forward for us.”

The FDA is not required to follow the advice of its advisory committee but it usually does.

April, 2015|Oral Cancer News|

FDA Approves Vaccine That Covers More HPV Strains

Source: webmd.com
Author: E J Mundell, HealthDay Reporter
 

WEDNESDAY, Dec. 10, 2014 (HealthDay News) — The U.S. Food and Drug Administration last Wednesday approved a new vaccine with expanded protection against the human papillomavirus (HPV), by far the leading cause of cervical and certain other cancers.

The agency said that Gardasil 9 can shield users against nine strains of the virus, compared to the four strains covered by Gardasil, the Merck & Co. vaccine approved in 2006. Merck also makes Gardasil 9.

“Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers,” the FDA said in an agency news release.

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “The approval of Gardasil 9 provides broader protection against HPV-related cancers.”

The U.S. Centers for Disease Control and Prevention currently recommends the HPV vaccine for boys and girls at age 11 or 12, so they are protected before being exposed to the sexually transmitted virus. One other HPV vaccine, Cervarix, was also approved by the FDA in 2009. Cervarix is made by GlaxoSmithKline and protects against two HPV strains strongly linked to cancer, HPV 16 and 18.

According to the FDA, the approval of Gardasil 9 was based on a clinical trial involving more than 14,000 girls and women aged 16 to 26 who were not infected with HPV at the start of the trial. Participants were given either Gardasil or Gardasil 9.

“Gardasil 9 was determined to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV types [31, 33, 45, 52, and 58],” the FDA said. “In addition, Gardasil 9 is as effective as Gardasil for the prevention of diseases caused by the four shared HPV types (6, 11, 16 and 18).”

For younger people — boys and girls aged 9 through 15 — Garadsil 9 was determined to be effective from measurements of immune-system antibody responses to the vaccine, the FDA explained. “Based on these results, the vaccine is expected to have similar effectiveness when used in this younger age group,” the agency said.

In terms of safety, the FDA said that the most common adverse effects were injection site pain, swelling, redness and headaches.

Like Gardasil, Gardasil 9 is administered as three separate shots, with the second and third doses given two and six months after the first one, respectively.

This year, about 12,360 new cases of invasive cervical cancer will be diagnosed, and about 4,020 women will die from the disease, according to the American Cancer Society.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
December, 2014|Oral Cancer News|

E-cigarette laws may be harder to regulate than originally thought

Source: apnews.com or ap.org
Author: Summer Ballentine & Michael Felberbaum
 

JEFFERSON CITY, Mo. (AP) – In a rush to keep electronic cigarettes out of children’s hands while the federal government creeps forward with a proposed national ban for minors, experts say that many states are passing laws that could mean fewer restrictions on the nicotine devices later.

Lawmakers last month made Missouri the 41st state to outlaw selling e-cigarettes to minors. Age restrictions have wide support, but Gov. Jay Nixon and public health advocates opposed a piece of the legislation that prevents tobacco taxes or regulations from being imposed on the electronic devices, which heat liquid nicotine into an inhalable vapor.

E-cigarette makers have been in a tug-of-war with state and federal governments since the battery-powered devices first were sold in the U.S. in 2007.

A 2009 law gave the U.S. Food and Drug Administration the power to regulate a number of aspects of tobacco marketing and manufacturing. It first said it planned to assert authority over e-cigarettes in 2011, but it hasn’t yet done so.

In April, the FDA for the first time proposed a set of regulations for e-cigarettes, including banning sales to minors and requiring health warning labels, as well as approving new products. The agency has said its proposal sets a foundation for regulating the products but the rules wouldn’t immediately ban the wide array of flavors of e-cigarettes or curb marketing on places like TV.

In the absence of regulation, members of Congress, state leaders and public health groups have raised concerns over e-cigarettes and questioned their marketing tactics. An FDA official said the agency has similar concerns and acknowledged that it has taken the agency too long to act.

“Part of what is driving those elected officials are public health concerns that we share about any aspect of the marketing of this emerging technology that is appealing to kids,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a recent interview with The Associated Press at the agency’s sprawling campus in suburban Maryland. “It took us too long to get the proposed rule out and we don’t intend a repeat of that as we go from proposed to final.”

Zeller did not give a timeline for when the final regulations would be in place, but has said any rules will have to be grounded in scientific evidence.

Scientists haven’t finished much research on e-cigarettes, and the studies that have been done have been inconclusive. The government is pouring millions into research to supplement independent and company studies on the health risks of e-cigarettes and other tobacco products – as well as who uses them and why.

Most lawmakers, as well as e-cigarette manufacturers, agree that they don’t belong in children’s hands. Yet as states enact age restrictions, experts say lawmakers could also be making it more difficult to regulate and tax e-cigarettes down the road if the FDA determines they’re unhealthy.

Of the states that have banned e-cigarette sales to minors, 31 have specified that e-cigarettes are “alternative nicotine” or vapor devices, not traditional tobacco cigarettes, according to the National Conference of State Legislatures.

Some lawmakers say these definitions would prevent e-cigarettes from later being treated as a tobacco product, but others disagree. Missouri’s law apparently is the first to explicitly state that e-cigarettes can’t be regulated or taxed as a tobacco product, said Michael Eriksen, dean of the School of Public Health at Georgia State University.

Regulations that currently apply to tobacco would restrict where the electronic cigarettes can be used, and how and where they can be advertised, among other things. Such regulations also would likely end the use of candy-flavored nicotine solutions, Eriksen said.

Laws skirting those restrictions have the blessing of e-cigarette companies, which contend that the devices aren’t the same as regular paper-and-tobacco cigarettes and don’t pose the same public health risks, so taxing and regulating them the same way doesn’t make sense.

Just six states classify e-cigarettes as a tobacco product, the NCSL reports. Only two states, Minnesota and North Carolina, have approved taxes on e-cigarettes, while three others, Michigan, Ohio and New York, are considering it.

Instead of adding e-cigarettes to existing tobacco laws that ban smoking indoors or tax the products, lawmakers in Missouri and possibly other states will have to create new tax structures and write regulations from scratch, said Mark Gottlieb, executive director of the Public Health Advocacy Institute at Northeastern University School of Law in Boston.

It’s a lot of work, he said, and unlikely to happen.

“In practice,” Gottlieb said, “this can hamstring the state and what it can do.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
 
 
October, 2014|Oral Cancer News|

Top cancer organizations push for FDA to regulate all tobacco products

Source: medicalexpress.com
Author: Staff

The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), in a joint letter responding to a proposal by the U.S. Food and Drug Administration (FDA) to extend its regulatory authority over tobacco products, today urged the agency to regulate electronic cigarettes (e-cigarettes), cigars, and all other tobacco products and to strengthen the proposed regulations for newly deemed products.

“There is no safe form of tobacco use,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “Tobacco is the leading cause of preventable deaths in the United States, and among its dire health consequences are 18 different types of cancer. It is imperative that the FDA takes action to regulate all tobacco products. The future health of the American people, in particular our nation’s children, depends on it.”

The AACR and ASCO applauded the FDA’s proposal to regulate e-cigarettes. “We believe it is vitally important for the FDA to begin regulating these products, especially because we don’t know much about the health effects of e-cigarette use. We are also quite concerned that e-cigarettes may increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or that they will discourage smokers from quitting,” said Peter P. Yu, MD, FASCO, president of ASCO.

“There are insufficient data on the long-term health consequences of e-cigarettes, their value as tobacco cessation aids, or their effects on the use of conventional cigarettes. Any benefits of e-cigarettes are most likely to be realized in a regulated environment in which appropriate safeguards can be implemented,” said Roy S. Herbst, MD, PhD, chair of the AACR Tobacco and Cancer Subcommittee and chief of medical oncology at Yale Comprehensive Cancer Center.

The AACR and ASCO support many of the FDA’s proposals for regulating e-cigarettes and other products, but urge the agency to do more. Specifically, preventing children from using tobacco products is crucial and can be achieved by efforts such as banning youth-oriented advertising and marketing, self-service product displays, and tobacco company sponsorship of youth-oriented events, in addition to restricting sales to minors and implementing age-verification procedures for internet sales.

Expressing grave concern about the proliferation of flavored e-cigarettes, the AACR and ASCO encouraged the agency to ban e-cigarette flavors or flavor names that are brand names of candy, cookies, soda, and other such products, and to prohibit e-cigarettes containing candy and other youth-friendly flavors, unless there is evidence demonstrating that they do not encourage young people to use these products.

The AACR and ASCO strongly discouraged the FDA from exempting “premium” cigars from regulation, an option the agency is considering. “All cigars pose serious health risks,” said Graham Warren, MD, PhD, chair of ASCO’s Tobacco Cessation and Control Subcommittee. “As the FDA itself noted in the proposed rule, even cigar smokers who do not inhale have a seven to 10 times higher overall risk of mouth and throat cancer compared with individuals who have never smoked. Exempting these dangerous products from FDA regulation is clearly not in the best interest of public health.”

Noting that both large and small cigars are of increasing interest to youth and adult users, the AACR and ASCO underscored that the continued availability of premium cigars in an unregulated market, compounded with the ability of the tobacco industry to strategically market its products to youths and young adults, could reverse the progress made in reducing youth tobacco use.

Finally, the AACR and ASCO urged the FDA to drop the “consumer surplus” discount used to assess the net impact of the proposed deeming rule. This discount allows the FDA to only consider 30 percent of the benefits achieved via tobacco cessation due to the costs associated with this proposed regulation, including the “lost pleasure” of smoking. The AACR and ASCO stressed that addiction is an unwelcome burden for many tobacco users and that many consumers are not making rational and fully informed choices when initiating and continuing their use of tobacco products.

More information: Read the joint AACR and ASCO letter to the FDA.

Provided by American Association for Cancer Research

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
August, 2014|Oral Cancer News|

Colgate Total ingredient linked to hormones, cancer spotlights FDA Process

Source: www.bloomberg.com
Author: Tiffany Kary

The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products.

At the same time, millions of Americans are putting it in their mouths every day, by way of a top-selling toothpaste that uses the antibacterial chemical to head off gum disease – Colgate-Palmolive Co.’s Total.

Total is safe, Colgate says, citing the rigorous Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug. A closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white — and weren’t, until this year, available to the public.

Colgate’s Total application included 35 pages summarizing toxicology studies on triclosan, which the FDA withheld from view. The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website.

The pages show how even with one of the U.S.’s most stringent regulatory processes — FDA approval of a new drug — the government relies on company-backed science to show products are safe and effective. The recently released pages, taken alongside new research on triclosan, raise questions about whether the agency did appropriate due diligence in approving Total 17 years ago, and whether its approval should stand in light of new research, said three scientists who reviewed the pages at Bloomberg News’s request.

Rodent Bones
Among the pages were studies showing fetal bone malformations in mice and rats. Colgate said the findings weren’t relevant. Viewed through the prism of today’s science, such malformations look more like a signal that triclosan is disrupting the endocrine system and throwing off hormonal functioning, according to the three scientists.

Colgate’s application materials also show that the FDA asked questions about the thoroughness of cancer studies, which are partly addressed in recently released documents.

Some questions about triclosan’s potential impact on people are, by nature, unanswerable. Humans are exposed to dozens of chemicals that may interact in the body, making it almost impossible to link one substance to one disease, said Thomas Zoeller, a biology professor at the University of Massachusetts Amherst, who specializes in how chemicals affect the endocrine system.

The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products.

‘Huge Risk’
“We have created a system where we are testing these chemicals out on the human population. I love the idea they are all safe,” Zoeller said. “But when we have studies on animals that suggest otherwise, I think we’re taking a huge risk.”

New York-based Colgate isn’t accused of wrongdoing, and the 35 pages don’t prove triclosan is harmful. It was the FDA’s decision to keep the documents off of its website, Colgate said.

The FDA followed standard procedure by redacting information that had come from a third party, said spokeswoman Andrea Fischer. Some studies were done in the labs of Ciba-Geigy, the first triclosan maker and a predecessor to its current primary maker, BASF SE, according to the documents. The pages didn’t denote which studies were done by an outside party, or who the party was. Fischer declined to identify them.

Fights Gingivitis
Colgate said Total’s effectiveness and safety are supported by more than 80 clinical studies involving 19,000 people, and that it gave the FDA 98 volumes, numbering hundreds of pages each, in support of Total. Colgate submits annual reports to the FDA reviewing new science and safety findings, said Colgate spokesman Thomas DiPiazza.

“In the nearly 18 years that Colgate Total has been on the market in the U.S., there has been no signal of a safety issue from adverse-event reports,” DiPiazza said. Colgate also pointed to an independent 2013 review by the Cochrane Oral Health Group, a network of doctors, researchers and health advocates, which found no evidence of harmful effects associated with using Colgate Total.

Total has an important health benefit because it fights plaque and gingivitis, DiPiazza said. Gingivitis can progress to periodontal disease, which affects almost half of Americans 30 and over, according to a 2012 study by the Centers for Disease Control and Prevention.

Soap Review
The FDA reviews all new safety information on ingredients to determine whether a reassessment is necessary, said Jeff Ventura, a spokesman. The agency is revisiting triclosan in hand soaps though not in Total, said Sandra Kweder, deputy director of the agency’s Office of New Drugs. That’s because while triclosan hasn’t been proven superior to soap and water at washing hands, she said, its benefit as an active ingredient in toothpaste was made clear through its FDA approval process.

Colgate removed triclosan from its Softsoap liquid handsoaps and Palmolive antibacterial dish liquid in 2011, citing changing consumer preferences and superior formulations. It said it has no plans to reformulate Total, which is the only triclosan toothpaste approved for U.S. sale.

This article is based on interviews with Colgate, former and current FDA staff and oral biology experts, transcripts of FDA meetings, as well as on the 35 pages, which the FDA shared in January with the Natural Resources Defense Council, a public-health advocate that sued for them. The scientists who examined the pages included Zoeller, a second university-affiliated endocrine specialist, and an environmental toxicologist affiliated with the Environmental Working Group, a public health advocacy.

Pet-Food Dispensers
Of the more than 84,000 chemicals sold in the U.S., few are attracting more scrutiny than triclosan. Used for decades in handsoaps, it is now part of almost 200 products including rugs and pet-food dispensers. Companies including Johnson & Johnson and Procter & Gamble Co. have vowed to remove it from their lineups. In May, Avon Products Inc. announced its plans to go triclosan-free.

Those moves are coming in part as consumers, armed with toxicity ranking systems such as the Environmental Working Group’s Skin Deep Database, have turned away from chemicals including Bisphenol A and phthalates, even in the absence of firm scientific or regulatory conclusions.

Wariness is mounting as factors from environment to diet are blamed for a global rise in endocrine-related diseases. Breast, ovarian, prostate and testicular cancer rates have increased over the past 40 to 50 years, according to a 2012 report from the World Health Organization and the United Nations Environment Programme. A rise in preterm and low birthweight babies, early breast development in girls and undescended testicles in boys may be linked to endocrine-disrupting chemicals, the report says.

Regular Exposure
Zoeller, the endocrine specialist, said that while an estimated 800 to 1,000 chemicals are believed to disrupt the endocrine system, triclosan is one of about 10 to which people are regularly exposed. “We may not have to change very much to have a big impact,” he said.

Total, the No. 3 selling brand in the U.S., lost 2 percent of its market share last year, with $189.8 million in sales for the year that ended on Jan. 26, according to market research firm Mintel Group Ltd. Colgate’s Tom’s of Maine line grew 14 percent, to $38.9 million, suggesting shoppers are gravitating toward more natural options, the report said.

Procter & Gamble, which makes Crest 3D White and Crest Pro-Health — the top two U.S. toothpastes according to Mintel — has sought to capitalize. A Google search for “triclosan” and “toothpaste” brings up an advertisement linked to a Procter & Gamble site touting Crest products as “100% triclosan free.”

Triclosan-Free
P&G’s oral-care products have been triclosan-free in the U.S. and several other markets “for a number of years,” said Kristopher Parlett, a spokesman for the Cincinnati-based company. P&G doesn’t produce or market triclosan-containing oral care products anywhere, he added.

GlaxoSmithKline Plc, which once had triclosan in some Aquafresh and Sensodyne toothpastes, has reformulated all of its oral care products that previously contained it, said spokeswoman Joanmarie Goddard. She couldn’t say what year they had been reformulated or whether triclosan versions had been sold in the U.S. The decision was a response to consumer concern that triclosan across a range of products “may have a negative environmental impact in the future,” she said.

Hand Scrubs
From its beginnings as an ingredient in surgical hand scrubs, triclosan — also identified as 5-Chloro-2-(2,4-dichlorophenoxy)phenol — has grown to a $100 million a year chemical globally, according to statistics from the Kline Group. BASF, based in Ludwigshafen, Germany, sells it under the trade names Irgasan and Irgacare. India-based Kumar Organic Products Ltd. and Vivimed Labs Ltd. also make it.

BASF says that 40 years of global studies and publications prove triclosan’s efficacy in oral care and cosmetic products, as well as in hand disinfectants and other health-care applications, according to Thomas Nonnast, a spokesman. Klaus Nussbaum, a spokesman for Kumar, said studies have established triclosan’s safety. Vivimed didn’t respond to requests for comment.

While company-sponsored safety tests on triclosan that would become part of Colgate’s FDA application for Total began as early as 1968, U.S. agencies have yet to comprehensively review it for other uses.

Safety Tests
In 1974, the FDA proposed issuing a so-called monograph that would determine whether antibacterial ingredients such as triclosan were considered safe and effective for hand soaps. Two years later, the U.S. Toxic Substances Control Act of 1976, which aimed to comprehensively regulate chemicals, grandfathered in existing substances with no safety testing.

The law gave the EPA — which oversees triclosan’s use in durable goods including fabrics and sealants — the power to restrict or test substances. It excluded food, drugs and cosmetics, which fall under the FDA’s mandate. The FDA, four decades after its first promise, has yet to issue a ruling on whether triclosan is safe or effective in soaps.

In the meantime, triclosan made its way into toothpaste.

Colgate spent 10 years and $38 million developing Colgate Total, according to Mintel. Introduced in 1992, it was marketed in almost 100 countries before gaining U.S. approval, according to transcripts of FDA meetings.

Four Applications
Colgate applied to the U.S. four times starting in 1992, according to FDA records, before gaining the FDA’s blessing on July 11, 1997. In a statement at the time, Colgate called Total “the most significant advancement in home dental care since the introduction of fluoride.”

In the early 2000’s, Caren Helbing, a professor at the University of Victoria in Canada, noticed the SARS outbreak in China had led to a germ-killing frenzy. Seeing triclosan listed as an active ingredient in many antibacterial products, she looked up its chemical structure. It was similar to both thyroid hormones and to polychlorinated biphenyls, or PCBs, she said. Such a structure, she and other scientists have said, allow the chemicals to become active on hormone receptors.

Helbing, who has a Ph.D. in biochemistry and microbiology, found that tadpoles exposed to triclosan developed into smaller froglets and had malformed legs — results that she and other scientists published in the peer-reviewed Aquatic Toxicology journal in 2006.

Thyroid Function
Other studies found no such links between the chemical and hormone function. A 2011 paper published in Science of the Total Environment found that over four years, the use of triclosan toothpaste had no detectable effect on thyroid function in humans. Three of that study’s five authors received a grant from Colgate. One, Greg Seymour, a professor at the School of Medicine at the University of Queensland, said Colgate requested the analysis of thyroid hormones after it granted them money for a separate study on gingivitis. Colgate had no input on data collection or analysis, he said.

The Cochrane paper, which Colgate cited in its favor, comes to a more complex conclusion. The review of more than 30 studies published from 1990 to 2012 found “moderate quality evidence” that Total is more effective than other toothpastes at fighting gum bleeding and inflammation. On the topic of safety, authors Philip Riley and Thomas Lamont, speaking about the review in a podcast, said the studies didn’t cover enough years to allow them to investigate any long-term ill effects.

Long-Term Exposure
“What I would be concerned about is the amount people are exposed to over time,” said William Bowen, a professor emeritus at the University of Rochester Medical Center, who specializes in oral biology and also served on a subcommittee at the FDA that evaluated dental products in the 1990s.

Meanwhile, triclosan is showing up in humans and the environment. It was found in the urine of 75 percent of 2,517 Americans tested, including children, according to a 2003 study by the Centers for Disease Control and Prevention. It and a related chemical, triclocarban, were detected in 90 percent of surface water samples from the Great Lakes and in many fish species, according to a July 2014 study by the Canadian Environmental Law Association.

Scientific studies that have raised health concerns include one 2012 study linking triclosan to reduced fertility in mice, and another that year suggesting it could impair muscle function. A study last year linked it to lowered sperm production and changed sperm shape in rats. Triclosan’s core credentials have also come under scrutiny: While some studies have supported its benefit in killing bacteria, others have found it no more effective than soap and water — and in some cases suggested it could support growth of bacteria including the type that causes staph infections.

EU Ban
In 2010, the European Union banned triclosan in materials that come into contact with food. Three years later, the EPA, which reviewed the chemical in 2008, began another review, 10 years earlier than planned. It cited the “rapidly developing scientific database” on the chemical, which includes studies on thyroid effects, according to its website.

Amid these debates, the Natural Resources Defense Council turned its attention to one of triclosan’s main regulators. In 2013, it sued the FDA for the toxicology data the agency had relied on in approving Colgate Total. In January, the FDA handed the NRDC the 35 pages and later put them online along with a previously unreleased cancer study and other information.

The pages included a summary of a 1992 study showing that pregnant mice receiving higher doses of triclosan had lower-weight fetuses and increased incidence of irregular bone formation in their skulls and paw bones. Five of the 120 mice delivered prematurely. A study on pregnant rats the same year found that at higher doses, rat litters had increased incidence of delayed bone formation in areas including the skull, vertebrae and pelvis.

The application dismissed both results — saying the premature births weren’t dose related and were therefore “incidental.” The bone-formation issues were due to toxic effects on the mother, not the fetus, the summary said.

Not Enough Detail
The summaries didn’t provide enough detail to justify those dismissals, according to the scientists reviewing them.

“Wow. They kept that private?” said Zoeller of the University of Massachusetts. “The distinction between maternal and fetal toxicity is an excuse to do nothing. And it’s not scientifically justifiable.”

Such results could have served as clues for later scientists if they had been made public, said the third reviewer, Johanna Congleton, a scientist at the EWG who has a PhD in Environmental Toxicology from Cornell University.

Amplified Effect
Since Total’s approval, researchers have gained new insights into chemicals that disrupt the endocrine system. The Total studies focused on whether triclosan had an amplified effect as exposure levels rose — a model consistent with a longstanding belief that the bigger the dose, the greater the poison.

Newer science has shown that even small doses of certain chemicals can significantly affect hormone functions, if they are delivered at the wrong moment — and that rising doses may cause new unpredictable effects, rather than a rising incidence of the same issue. Some of the data Colgate dismissed in the non-public pages are “almost a hallmark of endocrine disruption,” said Helbing, who conducted the study on frogs.

The effects Helbing had documented — smaller froglets and malformed legs — could be seen with doses equivalent to 1/10 of what a person would use in squeezing a pea-sized amount of Total onto a toothbrush twice a day, Helbing said.

The 35 pages of recently released documents also include a cancer study in which triclosan was fed to rats for as long as two years. FDA reviewers deemed the study inadequate, according to the recently released document, and called for another.

Industry Alliance
Shortly after, in February 1996, an FDA dental-products panel said the agency was working closely on a new cancer study with the Triclosan Industry Alliance — a trade group whose members, according to documents on the FDA’s website, included Colgate, Procter & Gamble and Ciba Specialty Chemicals. Colgate said it believes the alliance no longer exists.

According to the minutes of the meeting obtained through a Freedom of Information Act request, the study was expected in 18 months. Total was approved 17 months later. An industry group’s study was submitted to the FDA in 1999, said Colgate’s DiPiazza. Both Colgate and the FDA declined to make that study available.

Carcinogenicity Concerns
The FDA, in response to a Bloomberg News inquiry, said the agency’s concerns about carcinogenicity had been resolved by a cancer study that was submitted in January 1997. The study, which the FDA put on its website following a Bloomberg News inquiry, “supports the FDA’s conclusion that triclosan does not pose a cancer risk for humans,” DiPiazza said.

David Kessler, a former commissioner of the FDA from 1990 to 1997, just prior to when Colgate Total was approved, said he couldn’t comment on the thoroughness of the agency’s review. Typically, he said, only confidential commercial information is redacted from public documents. It’s the manufacturer’s responsibility, he said, to assure its product is safe and that relevant information is made public.

“The real question is did Colgate do a good job,” Kessler said.

Colgate continues to reference its FDA bona fides. This spring, Minnesota became the first state to pass a triclosan ban. Effective 2017, the state will prohibit the sale of triclosan-based cleaning products for the hands and body — except those with FDA approval, such as Total.

Colgate Lobbied

“Colgate came in and lobbied, and said it’s a good product,” said John Marty, a state senator who sponsored the bill.

The FDA, meanwhile, has vowed to deliver the monograph covering triclosan in handsoaps — the one it promised for the first time four decades ago — by 2016.

As part of that review, the agency will look at recent safety data on triclosan, said Kweder, the deputy director of the new drugs office. Kweder said the FDA doesn’t plan to revisit its Total decision but that if it finds concern in its broader review, it could look back into Total’s 1997 approval.

“But we would have to have a good reason to do that,” Kweder said.

August, 2014|Oral Cancer News|

FDA’s tobacco regulation draft proposal weakened by the White House

Author: Toni Clarke and Sharon Begley
Source: huffingtonpost.com
 
 

WASHINGTON, June 25 (Reuters) – White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes, published documents show.

The White House’s Office of Management and Budget (OMB), which analyzes the potential economic consequences of proposed regulations, deleted language in the U.S. Food and Drug Administration’s recently proposed regulations describing how the rules would keep thousands of people from taking up cigar smoking and have enormous public health benefits.

The OMB also weakened language detailing the FDA’s concerns about the safety of e-cigarettes, according to documents published Tuesday in the Federal Register.

Emily Cain, a spokeswoman for OMB, said that as with any rule, OMB’s office of information and regulatory affairs conducted an interagency review process “to ensure that the regulations through which agencies implement policies are efficient, well-designed to achieve their objectives, and based upon the best available evidence.”

“It is routine for agencies to make changes to their draft rules during the course of OMB review,” she added. “The goal is to maximize the effectiveness and benefit of the rules we complete.”

An FDA spokeswoman, Jennifer Haliski, said the FDA does not comment on changes to a proposal during the review process but said the period for the public to comment on the proposal is still open until Aug. 8.

“All comments will be carefully considered as the final rule is being developed,” she said in an email. “As the science base continues to develop for these products, the agency has the ability to take additional regulatory actions designed to further minimize the public health burden of tobacco use in this country.”

The FDA has authority under a 2009 law to regulate cigarettes, smokeless tobacco and roll-your-own tobacco, but must issue new rules before regulating e-cigarettes, cigars, hookahs, water pipes and other tobacco products.

In April, the FDA issued a proposal which would subject the $2 billion e-cigarette industry to federal regulation for the first time. It would ban the sale of e-cigarettes to people under the age of 18 and vending machine sales.

The proposal disappointed public health advocates who criticized the agency’s failure to restrict flavored products or television advertising, which they say attracts children, and criticized the agency for not moving to restrict online sales, where it can be harder to verify a person’s age.

In its draft, the FDA had proposed “prohibition of non-face-to-face sales (e.g. vending machines).” That would have opened the door to a ban on online sales. But OMB edited the sentence so that the prohibition refers only to vending machines.

In another significant change, OMB turned the FDA’s proposal as it relates to cigars from a two-part rule – one for traditional tobacco products and one for products that have not previously been regulated – into a “two-option” rule, one of which would exempt “premium cigars.”

The cigar industry, backed by some members of Congress, had lobbied OMB heavily for such an exemption. In a December 2013 letter to FDA Commissioner Margaret Hamburg and Sylvia Mathews Burwell, who was director of OMB at the time and is now Secretary of Health and Human Services, 24 Republican lawmakers asked that premium cigars be exempt.

“As you know,” they wrote, “premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings.”

When the proposed rule came out in April, some public health advocates expressed dismay.

“The part of the proposal we are deeply troubled by is the sweetheart deal for the cigar industry,” Erika Sward, assistant vice president for national advocacy at the American Lung Association.

OMB also deleted an FDA analysis showing that exempting premium cigars from a proposal to require large warning labels would save manufacturers $1 million to $3 million but incur costs to public health of $32.6 million to $34.2 million.

The White House office also deleted an extensive section in which the FDA calculated how many lives would be saved by regulating cigars, as well as the value of those lives. And it deleted a similar analysis for the improvements in health that would come from dissuading people from smoking cigars, such as through warning labels.

The “welfare gain” from reducing the number of cigar smokers, FDA calculated, would be $16 million to $52 million.

Similarly, OMB modified or deleted FDA concerns about the safety of e-cigarettes, including manufacturing quality.

It deleted FDA draft language saying it would review electronic cigarette cartridges to respond to evidence of poor quality control, variable nicotine content or toxic ingredients such as diethylene glycol, a chemical that the FDA said has caused mass poisonings in products such as the painkiller acetaminophen and cough syrup.

Last week a panel of U.S. senators excoriated the chiefs of two of the biggest e-cigarette companies, blu eCigs, which is owned by tobacco giant Lorillard Inc, and privately held NJoy, saying they were irresponsibly targeting children with advertisements depicting cartoon characters, movie stars and other celebrities.

Both companies defended the advertisements, saying they target adult smokers.

 
* This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
June, 2014|Oral Cancer News|

FDA proposes rules to disclose e-cigarette ingredient information and ban sales to children

Source: usatoday.com
Author: Wendy Koch

 

As electronic cigarettes soar in popularity, the U.S. government Thursday is proposing historic rules to ban their sale to minors and require warning labels as well as federal approval.

Three years after saying it would regulate e-cigarettes, the Food and Drug Administration is moving to control not only these battery-powered devices but also cigars, pipe tobacco, hookahs (water pipes) and dissolvable tobacco products. Currently, the FDA regulates cigarettes, roll-your-own tobacco and smokeless products such as snuff.

The proposed rules won’t ban advertising unless the products make health-related claims nor will they ban the use of flavors such as chocolate or bubble gum, which public health officials say might attract children.

“This is an important moment for consumer protection,” said FDA Commissioner Margaret Hamburg, noting tobacco remains “the leading cause of death and disease in this country.” The rules will require manufacturers to report their ingredients to the FDA and obtain its approval. They also ban free tobacco samples and most vending-machine sales.

“Some of these regulations will be very restrictive,” said Ray Story, founder of industry group TVECA (Tobacco Vapor Electronic Cigarette Association), who added he obtained his own pre-release copy of the rules. He said they could be costly for smaller businesses and slow the growth of a product that advocates say has helped many smokers kick the habit.

Still, Story said, consumers might benefit, because “it provides them a product that will be consistent.” E-cigarettes contain varying ingredients and levels of nicotine that are heated into a vapor that users inhale in a practice known as “vaping.” Most look like conventional cigarettes but some resemble everyday items such as pens and USB memory sticks.

The rules come as e-cigarette sales, buoyed by TV ads with Hollywood celebrities , have soared in recent year and debate has risen about whether the devices are more apt to lure kids toward tobacco or help adults quit smoking.

An increasing number of states have cracked down by extending indoor smoking restrictions to e-cigarettes. Last month, U.S. poison centers reported a surge in illnesses linked to the liquid nicotine used in the devices.

While they don’t contain many of the harmful chemicals of conventional cigarettes, the FDA found trace amounts of toxic and carcinogenic ingredients in several samples in late 2008 when the e-cigarette market was just beginning in the United States. It sought to regulate them as drug-delivery devices, but in 2010, a federal judge ruled it could only do so if they made therapeutic claims. So in April 2011, the agency said it would regulate them as tobacco products, because the nicotine is derived from tobacco leaves.

“It’s taken more than three years to issue a proposed rule, which we think is inexcusable,” said Vince Willmore of the Campaign for Tobacco-Free Kids, an anti-smoking group. “It’s allowed a Wild West marketplace with irresponsible marketing and no control over the product.” He says the FDA should quickly finalize the rules, which face a 75-day public comment period and further review.

The proposed rules walk a narrow path. They will require tobacco products that weren’t on the market by Feb. 25, 2007 — a date set by a federal law — to apply for FDA review within 24 months after the rules are issued. The products can stay on the market pending FDA’s review, says Mitch Zeller, director of FDA’s Center for Tobacco Products, adding they can seek an exemption from additional reviews if minor changes are made.

Despite these requirements, the proposal doesn’t contain the marketing restrictions sought by some critics that were almost sure to trigger litigation. Craig Weiss, CEO of NJoy, a top-selling e-cigarette, said he supports “reasonable regulation” but would “respond very forcefully to any attempt to limit my free speech right to promote my product.”

Several dominant e-cigarette manufacturers, which now include the nation’s three largest cigarette makers — Philip Morris, R.J. Reynolds and Lorillard — have embraced limited regulation such as a ban on sales to minors. Yet they’ve argued that their e-products shouldn’t be regulated as tightly as conventional cigarettes — an approach the FDA appears to be taking.

The FDA said the rule aims to bolster product safety. It said since e-cigarettes have not been fully studied, consumers have no way to know how much nicotine or other chemicals they contain and whether they’re safe or beneficial.

 

FDA’s 20-year road to regulating tobacco:

August 1996: FDA issues rules to ban tobacco sales to minors and its advertising near schools or playgrounds

March 2000: U.S. Supreme Court, in 5-4 decision, rules that Congress did not give FDA such authority

December 2008: FDA, after detaining import shipments of e-cigarettes, declares they’re unapproved drug delivery devices

April 2009: E-cigarette distributor Smoking Everywhere files suit against the FDA, joined a month later by Sottera (doing business as NJOY)

June 2009: Congress passes law granting FDA authority to regulate tobacco products

January 2010: U.S. District Court for the District of Columbia bans FDA from stopping e-cigarette imports

June 2010: FDA issues final rules to ban the sale of cigarettes and smokeless tobacco to minors and to restrict their marketing

December 2010: U.S. Court of Appeals for the D.C. Circuit, upholding lower court decision, rules e-cigarettes can be regulated as tobacco products but not as drugs/devices unless marketed for therapeutic purposes

April 2011: FDA says it intend to expand to its authority over tobacco products to include e-cigarettes

June 2011: FDA issues new graphic warning labels that will need to be placed on cigarette packs and ads by Sept. 2012

April 2014: FDA proposes rules to regulate e-cigarettes and cigars as tobacco products

 

* This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

 

April, 2014|Oral Cancer News|

Current tobacco reports show 50 years of progress

Source: the-scientist.com
Author: Jef Akst

 

In 1964, the U.S. Surgeon General released the first report on the effect that cigarettes and other forms of tobacco have on human health, presenting strong evidence of the link between smoking and lung cancer, among other adverse consequences. During the last 50 years, significant progress has been made in terms of understanding how smoking causes various diseases and how to treat them, and educational campaigns have contributed to a drop in smoking rates from 42 percent to 18 percent of US adults. Nevertheless, more than 480,000 Americans still die from tobacco-related diseases each year, and additional health consequences continue to be linked to smoking.

“Between now and mid-century, nearly 18 million Americans will die preventable avoidable deaths if we don’t do something to alter that trajectory,” Mitchell Zeller, the director of the Center for Tobacco Products of the Food and Drug Administration (FDA), said during a press conference held today here at the American Association for Cancer Research (AACR) meeting in San Diego, California.

To this end, the AACR released a compilation of peer-reviewed research and review articles, published across seven of its journals, covering basic scientific research on the molecular mechanisms of tobacco carcinogenesis, tools for the diagnosis of lung cancer and other tobacco-related diseases, and the impact of the original Surgeon General’s report on tobacco control. Ellen Gritz from the University of Texas MD Anderson Cancer Center helped put the new report together. “Together, these reports add to the broad reach of important tobacco-related research at the forefront of cancer research and policy, and shine a light on both the challenges and opportunities ahead,” Gritz said.

“[The report] drives home the need for action, citing this large burden of smoking-attributed premature death and morbidity, . . . [and] ends with a call for more action,” added Jonathan Samet, a pulmonary physician and epidemiologist at the University of Southern California.

In addition to the special report, AACR today hosted speakers from the FDA, the National Cancer Institute (NCI), and other groups to discuss the way forward for tobacco-related research, education, and regulation. “Clearly, if you think about other domains of health and risk, if a consumer product were to be introduced onto the market which caused a few dozen deaths it would easily make national news, and produce a public outrage, 60 Minutes reports, headlines,” said Robert Croyle, who directs the Division of Cancer Control and Population Sciences at NCI. “But we’re in a bizarre situation where we have a legal product on the market that’s responsible for about half a million deaths [each year].”

Zeller pointed to several recent FDA initiatives aimed at reducing tobacco-related deaths, including education campaigns targeting young people. Like the other panelists, Zeller praised the progress that has been made, noting the “remarkable denormalization of tobacco use” since a time when his parents would put out bowls of loose cigarettes at parties, and when he and his classmates would make ashtrays in arts and crafts class. But he emphasized that the fight is far from over. “As we pause to acknowledge all of that progress, we also have to take stock of the work that lies ahead of us,” Zeller said.

 
 *This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
 
 
April, 2014|Oral Cancer News|