Wednesday, March 7, 2012

News and Events - 08 Mar 2012




NHS Choices
05.03.2012 19:35:00

“Ice cream 'could be as addictive as cocaine',” reported the Daily Mail. In a bid to scoop its rivals, the newspaper claimed that new research had whipped up “concerns that the dessert could be genuinely addictive”.

It’s not clear who exactly had these chilling “concerns” over the possible addictive qualities of the frozen snack, but the study in question looked at measures of brain activity in 151 teenagers while they drank an ice cream milkshake. During the scans, teenagers who had frequently eaten ice cream over the past two weeks showed less activity in the “reward areas” of the brain that give pleasurable sensations. This reduced reward sensation was reported to be similar to what is seen in drug addiction as users become desensitised to drugs.

Unsurprisingly, the study did not directly compare brain responses to or cravings for ice cream with those for illegal drugs. Therefore, while some aspects of the brain’s response may be similar, it is not correct to say that this study has found that ice cream is “as addictive” as illegal drugs.

It should be noted that the study included only healthy teenagers of normal weight, and its results may not represent overweight or older people. It also only tested one food, so the results may not apply to other foods.

 

Where did the story come from?

The study was carried out by researchers from the Oregon Research Institute in the US. Sources of funding were not clear. The study was published in the  peer-reviewed American Journal of Clinical Nutrition.

The newspapers focused on the suggestion that ice cream is “as addictive” as drugs. However, it is not possible to conclude this from the study.

 

What kind of research was this?

This experimental study looked at whether regularly eating ice cream reduces the brain’s pleasurable “reward” response. When we do things that support our survival, such as eating and drinking, the brain gives us a pleasurable reward sensation, reinforcing this behaviour and encouraging it in future. A similar process is also believed to occur in drug addiction, where a person’s reward response to the drug decreases with repeated exposure, leading to a need to take more of the drug.

The researchers reported that people who are obese experience less of a response to food in the reward centres of the brain, which may contribute to over-eating. Repeatedly eating foods with high levels of calories (called “energy dense” foods has also been shown to lead to brain changes that reduce reward response in rats. The researchers wanted to see if a similar thing happens in humans, by looking at whether regularly eating ice cream reduces the brain’s pleasurable reward response to an ice cream milkshake.

 

What did the research involve?

The researchers recruited 151 adolescent volunteers who were not overweight. They asked them how often they ate ice cream, and carried out brain scans while they drank either a tasteless solution or an ice cream milkshake. They then looked at whether the volunteers who ate ice cream frequently showed less brain activity in the reward centres of the brain when drinking the ice cream milkshake.

The study excluded any individuals who were overweight or had reported binge eating in the past three months, as well as any who had used illegal drugs, took certain medications, had a head injury or a mental health diagnosis in the last year. The volunteers completed standard food questionnaires about their eating habits over the past two weeks, including how often they ate ice cream. They also answered questions about food cravings and how much they liked certain foods, including ice cream. The volunteers also had their weight, height and body fat measured.

Volunteers were asked to eat their meals as usual but not to eat anything for five hours before the brain scan. The researchers then gave them either a sip of chocolate ice cream milkshake or a tasteless solution, and monitored the activity in their brain. Each participant received both drinks in a randomised order. The researchers then looked at what happened in the brain during each drink, and whether this varied depending on how much ice cream the volunteer usually ate. They also looked at whether body fat or energy intake from other foods influenced the response.

 

What were the basic results?

The researchers found that when the volunteers drank the ice cream milkshake, it activated the parts of the brain involved in giving a pleasurable “reward” feeling. Volunteers who ate ice cream frequently showed less activity in these pleasurable reward areas in response to the milkshake. Percentage of body fat, total energy intake, percentage of energy from fat and sugar, and intake of other energy-dense foods were not related to the level of reward response to the milkshake.

 

How did the researchers interpret the results?

The researchers concluded that their findings show that frequent consumption of ice cream reduces the “reward” response in the brain to eating the food. They reported that a similar process is seen in drug addiction.

The researchers also said that understanding these sorts of processes could help us understand how changes in the brain may contribute to, and help maintain, obesity.

 

Conclusion

This brain-scanning study suggests that the brain’s pleasurable reward response to ice cream decreases if it is eaten frequently. There are some points to note:

  • The study only included healthy adolescents who were not overweight. Its results may not be representative of overweight or older individuals.
  • The study only tested one food, so the results may not apply to other foods.
  • Volunteers’ eating habits were only assessed for the past two weeks, and these may not be representative of their long-term eating habits.
  • The study did not look at any other food with a discernable taste, only a “tasteless liquid”. It would have been interesting to see whether the reward response with tasting other foods, including less energy-dense foods, also diminished over time.
  • News reports claimed that this study shows that ice cream is “as addictive” as illegal drugs, but this is not the case. While the reduced brain reward seen with frequent ice cream eating was reportedly similar to that seen in the use of addictive drugs, the study unsurprisingly did not directly compare brain responses to ice cream and illegal drugs, or their addictive potential.

Analysis by Bazian

Links To The Headlines

Ice cream 'could be as addictive as cocaine', as researchers reveal cravings for the two are similar. Daily Mail, March 5 2012

Ice cream as 'addictive as drugs' says new study. The Daily Telegraph, March 5 2012

Links To Science

Burger KS and Stice E. Frequent ice cream consumption is associated with reduced striatal response to receipt of an ice cream–based milkshake. February 15 2012




07.03.2012 13:05:00

Lynne Taylor

CNS drugs take 35% longer to develop than others: study

Drugs being developed for the treatment of diseases of the central nervous system (CNS take 35% longer to complete clinical trials and receive regulatory approval than other new prescription medicines, according to a new analysis.

Between 1996 and 2010, the mean clinical-plus-approval-phase time for CNS drug treatments approved in the US was 32 months, 35% longer than the mean for non-CNS drugs approved during the same period, according to the analysis, which is published by the Tufts Center for the Study of Drug Development (CSDD .

But despite the longer and more costly development associated with CNS drugs, "the CNS new product pipeline is among the richest in the R&D-based drug industry," comments Joseph DiMasi, who conducted the study and is director of economic analysis at the Tufts Center.

The industry's CNS drug pipeline includes products to treat neurological diseases such as Alzheimer's disease, epilepsy, migraine headaches and stroke, and mental health conditions such as addictions, autism, depression, panic and schizophrenia.

The pipeline has grown by an annual average of 6% over the last decade and currently accounts for 11% of all drug development projects worldwide, the study notes. Nevertheless, development of these treatments poses a challenge for drugmakers, with the clinical approval success rate for "self-originated" CNS drugs entering clinical trials between 1993 and 2004 estimated at about one in 10. That compares to around one in six for all self-originated drugs, according to the study, which goes on to explain that "self-originated" drugs are those developed entirely by one manufacturer, in contrast to compounds which a company may obtain through licensing, purchase or other means.

Also, the "clinical approval success rate" refers to the share of New Chemical Entities (NCEs in clinical development that eventually obtain marketing approval from the US Food and Drug Administration (FDA .

The analysis is reported in the March/April issue of the Tufts CSDD Impact Report. It also reveals that the clinical approval success rate for self-originated CNS drugs varied from a low of 7.1% for products entering clinical testing during the period from 1995 to 2000 to 14.8% - or more than double - for drugs which entered clinical testing during 1998-2003.

It also notes that the mean clinical time for CNS drugs during 1996-2010 was 102.1 months, which is 40% longer than for non-CNS drugs, while the mean approval time for these products was 20.3 months, or 13% longer than for non-CNS treatments.

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ggoetz@foodsafetynews.com (Gretchen Goetz
06.03.2012 12:59:07
Today's leading cola beverages contain high levels of a substance linked to cancer in animals, according to new research. 
An independent study commissioned by the
Center for Science in the Public Interest (CSPI uncovered  4-methylimidazole, or 4-MI, in Coke, Diet Coke, Pepsi and Diet Pepsi at levels 4.8 times greater than those allowed in beverages in California.
4-MI is a byproduct of the reaction that produces the caramel coloring in brown sodas. The chemical has been found to be carcinogenic in animal studies.   
The state of California has banned 4-MI in any amount that could potentially lead to one cancer case in 100,000 people. However the levels found in these 4 leading Cola brands indicated a lifetime risk of 5 cancers out of 100,000, assuming that people drink one soft drink per day. That risk rises to 10 cancers out of 100,000 people who drink only soft drinks containing caramel coloring. 
The federal Food and Drug Administration (FDA sets an even more conservative risk limit for contaminant in food additives of 1 cancer in 1,000,000 people.  But the study reported rates of 4-MI that are associated with 48 cancers in 1,000,000. 
"Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer," said CSPI executive director Michael F. Jacobson.  "The coloring is completely cosmetic, adding nothing to the flavor of the product.  If companies can make brown food coloring that is carcinogen-free, the industry should use that.  And industry seems to be moving in that direction.  Otherwise, the FDA needs to protect consumers from this risk by banning the coloring." 
In a
letter to FDA Commissioner Margaret Hamburg Monday, CSPI shared the results of its study. The document served as an addition to the group's petition of last year, which called on FDA to ban caramel colorings made with processes that generate 2-MI and 4-MI. 
The study also found 4-MI in Dr. Pepper and Diet Dr. Pepper, but at lower levels than the other 4 brands. A sample of Whole Foods' 365 cola had a concentration of 47 micrograms of 4-MI in a can, as opposed to the almost 150 micrograms found in a can of Coca-Cola. 
The beverage industry responded to the study by pointing out that the European Food Safety Authority (EFSA , Health Canada and FDA have approved caramel coloring as safe for use in food and drink. 
"This is nothing more than CSPI scare tactics, and their claims are outrageous," responded the American Beverage Association. "The science simply does not show that 4-MEI in foods or beverages is a threat to human health. In fact, findings of regulatory agencies worldwide, including the U.S. Food and Drug Administration, European Food Safety Authority and Health Canada, consider caramel coloring safe for use in foods and beverages. CSPI fraudulently claims to be operating in the interest of the public's health when it is clear its only motivation is to scare the American people."
Coca-Cola defended its product. 
"Unlike CSPI, The Coca-Cola Company deals in hard facts," said company representative Ben Sheidler in an e-mailed statement to Food Safety News. "Fact:  The body of science about 4-MEI in foods or beverages does not support the erroneous allegations that CSPI would like the public to believe.  The 4-MEI levels in our products pose no health or safety risks.  Outside of California, no regulatory agency concerned with protecting the public's health has stated that 4-MEI is a human carcinogen.  The caramel color in all of our ingredients has been, is and always will be safe. That is a fact."  
FDA spokesman Doug Karas said the findings of the report were not of concern to consumer health. 
"A person would have to drink more than a thousand cans of soda in a day to match the doses administered in studies that showed links to cancer in rodents," he told Bloomberg. 
The analysis was limited to 13 samples - 1 of Whole Foods' 365 and 2 of each other brand - all purchased in the Washington, D.C. area. 
This article has been updated since its original publication. 




06.03.2012 1:18:00

WASHINGTON – Katrice Bridges Copeland used to defend pharmaceutical company executives when their companies were accused of fraud.>But when she saw that Pfizer, after being accused of fraud, had entered a third corporate integrity agreement with the government and paid $2.3 billion in fines to avoid being excluded from doing business with Medicare, Copeland said she was infuriated. She sat down and wrote a 63-page paper encouraging more effective measures to get companies to comply.

"That's not even a quarter of their profits," said Copeland, a law professor at
Pennsylvania State University. "I was up in arms."

Government officials say they are, too, and they've talked about incorporating some of Copeland's ideas.

"That's a question we've been struggling with for the last couple of years," said Gregory Demske, assistant inspector general for legal affairs at Health and Human Services. "We recognize there's a problem."

If a company is excluded from doing business with the government, then medications that only those companies produce will not be available to beneficiaries. But, Copeland said, the fees associated with corporate integrity agreements haven't been enough to keep companies from bilking the government again.

"It's still in the company's interest to promote off-label marketing because they're still going to make more in profits than they lose in fines," she said.

HHS officials are talking with those at the
Justice Department and Food and Drug Administration to fix the problem, Demske said.

Most of the cases come from off-label marketing of prescription medications. For example, Pfizer was accused of marketing Bextra, a painkiller, for uses other than what the
FDA had approved. Such uses constitute fraud because they take government money for purposes the FDA has not approved.

Instead of excluding an entire company from doing business with the government, Copeland said, the drug being marketed off-label could be excluded.

HHS officials considered that, Demske said, but they needed to ensure that beneficiaries could get their medications. The agency is considering taking away a company's patent rights as part of a settlement with the government.

That, he said, would allow other companies to make and sell the drugs to the government. Such a deal could be negotiated with companies as part of a fraud settlement and would not require congressional approval.

"We could require other things if the defendant will agree to it," he said. "If not, there might not be a settlement."

And if there's no settlement, there may be an exclusion.

Copeland suggested requiring companies to conduct clinical trials for the off-label uses they were accused of, requiring that they license a product to other manufacturers and holding high-level individuals criminally liable. Demske said that investigators began going after individuals in companies in 2010 and that they have focused resources on that idea.

Pfizer,
Bristol-Myers Squibb and
Abbott Laboratories did not respond to questions from USA TODAY.

"Imposing such a severe penatly on a person who had no knowledge of the wrongdoing at issue is manifestly unfair and unjust," said
Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America.

The Supreme Court ruled in the 1970s that the government may go after officials who should have knowledge that fraudulent behavior is happening under their management. However, the law applies only to individuals holding a position at a company.

"If they leave, we can't reach them," Demske said. "The law is written in present tense."

The government has to send a note notifying the person that it is considering excluding them, which leaves the person plenty of time to leave the company.

"They would be free to work elsewhere," Demske said.

A bill to address the problem passed the House last year but hit the Senate too late in the session to make it to a vote. A new bill, HR 675, has been introduced.

Officials with the Centers for Medicare and Medicaid Services are looking for answers, said Ted Doolittle, deputy director of CMS' Center for Program Integrity. Instead of excluding a company, the CMS can revoke payment, which the government plans to do more aggressively, he said.

Last month, 78 home health care agencies in Texas were suspended in connection with a fraud case, and Doolittle said the CMS will not pay them for services until they are cleared of wrongdoing. First, he said, the CMS had to make sure beneficiaries would be able to get the services they need if those centers were out of business.

Congress members have suggested mandatory exclusions for crimes, but Copeland said the cases often don't reach that point because the parties settle before a proclamation and because the government has to worry about patient access.

If the government targeted individuals more aggressively, that could send a powerful message to drug companies, said Stan Twardy, leader of law firm Day Pitney's health care compliance group.

"Something called a jail is going to send a lot stronger signal than a fine," he said. "The regulations can change, but individuals and companies will take advantage of any loopholes they may find. It's part of that game of maximizing profits."

Under a system of agreements and fines, he said, the corporate culture will remain the same.

Copeland said she doesn't think that's enough.

"If you go after the sales manager because the sales manager could have prevented the fraud, it doesn't change the corporate culture," she said. "The more prescriptions, the more money you make, so the incentive remains."

Patrick Burns, spokesman for the non-profit Taxpayers Against Fraud, said although there may be differences of opinion, there is a greater sense or urgency about fighting the problem.

"We're all thinking the same thing," Burns said of investigators and Congress members. "The good news is they're pushing to actually do it."

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info@foodsafetynews.com (News Desk
06.03.2012 12:59:05
On March 1, Joan Murphy of the Produce News wrote that produce trade organizations will be meeting to draft additional guidance to ensure the safe production of netted melons (i.e. cantaloupe .  The move is in response to the
2011 Listeria monocytogenes outbreak that was traced to cantaloupes produced by Colorado-based Jensen Farms, sickened 146 and killed more than 30. 
According to
Murphy's report, the meetings are open to growers, buyers, and auditors in the produce industry, as well as regulators from state agencies, the Food and Drug Administration and the U.S. Department of Agriculture.  However, the meetings will not be open to the public - a decision that has left many Listeria victims and their families feeling ignored.
"If the full weight of our losses is not recognized by those in industry, how can they make fully informed decisions regarding the importance of improved practices?" asks Kathleen Gilbert Buchanan, whose mother, Frances Gilbert, died in September from a Listeria infection.   "Treating all of the illnesses and deaths as mere statistics will not have the same impact as hearing the voices of our families and seeing the faces of our loved ones."
Jennifer Exley, the daughter of a Colorado man who was
hospitalized for over a month and still requires in-home health care believes that the cantaloupe industry needs to hear the victims' side of the outbreak in order to fully understand the real-life impact of foodborne illness.
"They need to know our stories," said Exley. "People that have been affected should be allowed to speak about what we all have been through and are continuing to go through so the seriousness of foodborne illnesses can be relayed in a personal manner."
In October, the Associated Press
published a story about the death of George Drinkwalter. Despite the Drinkwalter family's initial hope  that awareness of their loss might lead to cantaloupe safety improvements, the family now says the decision of the cantaloupe industry has dampened any expectation of real change. "We feel tremendously let down and ignored. This is very disappointing for those of us who lost a family member in this outbreak, said Drinkwalter family spokesman Keith Drinkwalter. "After the deaths of over 35 people, I would think that the industry would want to be open and upfront with upcoming discussions."




07.03.2012 5:46:00

A U.S. unit of
Takeda Pharmaceutical Co. (4502 failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes drug Actos, a whistle-blower claimed in a lawsuit.

The company failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010, former Takeda medical reviewer Helen Ge said in the complaint in federal court in
Boston. Takeda, like other drugmakers, is required to update the U.S.
Food and Drug Administration’s Adverse Event Reporting System.

“These events were not properly identified or reported in the FDA’s safety database,” Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”

The case against Takeda Pharmaceuticals North America Inc., filed by Ge on the government’s behalf, became public after the U.S. Justice Department declined to join it on Feb. 22. Twenty- four U.S. states also declined to join Ge’s complaint, said one of her attorneys, Michael L. Baum.

Generic Copies

Takeda, based in
Osaka,
Japan, said Feb. 1 that annual profit will fall 48 percent to 130 billion yen ($1.6 billion in the year ending March 31. Sales of Actos, which generated 27 percent of revenue last fiscal year, declined 19 percent in the previous nine-month period and will slump more when it faces competition from generic copies in August, Takeda said.

Jocelyn Gerst, a spokeswoman for Takeda, didn’t immediately return a call or e-mail seeking comment on the complaint.

Ge’s complaint claims that on “multiple occasions,” Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” When she protested, “her contract was summarily terminated,” according to the complaint.

Takeda wanted to make it appear that Actos was safer than GlaxoSmithKline Plc’s Avandia diabetes drug, according to the complaint.

‘Systematic Fraud’

Ge sued under the federal
False Claims Act and similar state statutes, and seeks to recover damages on behalf of governments. She would be entitled to between 15 and 30 percent of any recovery.

“Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” causing “hundreds of millions of dollars” in damages, according to the complaint.

In 2007, the FDA ordered Takeda and Glaxo to place its strongest warning on the labeling of their drugs about the risk of congestive heart failure, a condition that occurs when the heart doesn’t adequately pump blood.

Ge claimed that Takeda’s culture is “riddled with systematic fraud and deceit,” and that the company downplayed data suggesting a link between Actos and bladder cancer.

Baum, of Baum, Hedlund, Aristei & Goldman, said he is undeterred by the
Justice Department’s decision to not join the lawsuit after investigating. The U.S. declines to join four out of five cases filed under the False Claims Act. Companies settle the vast majority of cases when the U.S. intervenes.

“I believe that the documents we obtain in discovery will induce the government to come back in,” Baum said. “But whether they come back in or not, I believe the documents will show that the company violated the False Claims Act.”

One of Ge’s lawyers is
Michael Sullivan of The Ashcroft Group LLC. He is the former U.S. attorney in Boston.

The case is U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of
Massachusetts(Boston .

To contact the reporter on this story: David Voreacos in Newark at
dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at
mhytha@bloomberg.net.

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2012-03-06 11:57:20
Chen Yi Liang, a former chemist with the Food and Drug Administration (FDA , has been sentenced to five years in prison for using his access to the agency’s drug approval process in an insider trading scheme. U.S District judge Deborah Chasanow preceded over the hearing against the former FDA chemist who was found guilty of insider trading on Monday. Liang, the retired FDA chemist, pleaded guilty to two counts of felony last fall, one for concealing trading activities and the other for securities fraud. Though the five year sentence was less than what the federal government had requested, it was more than double the length that Liang’s attorney had suggested. New drug approvals are often sensitive and quite a visible area for the agency, and as such the news of Liang's case sent shockwaves throughout the FDA. Such a case is rare within the agency, which prides itself on its rigorous ethical standards. Employees of the FDA are also subject to strict trading restrictions. Upon the announcement of his case, Chen Yi resigned in March 2011. Liang admitted that he had made more than $3.7 million from trading pharmaceutical stocks between 2006 and March 2011. He used his inside information about the FDA’s drug approval process to buy and sell stock. If Liang knew that an upcoming agency announcement would shed positive light on a new pharmaceutical, he would buy stock in that company. Alternatively, when he knew that negative news was forthcoming, he would sell short those companies. Liang would then close his positions after the FDA released their information. For example, Mr. Liang traded Vanda Pharmaceuticals ahead of a 2009 announcement that the FDA had approved its drug Fanapt. Chen Yi’s son, Andrew Liang, was also arrested last March on similar charges. Sharing several brokerage accounts, the Liangs gathered more than $1 Billion in profits, comprising nearly 800 percent profit, according to court documents. The 58 year old Ex-FDA chemist agreed to relinquish his $3.7 million in profits as well as his home in Gaithersburg, Maryland. The younger Andrew Liang received a sentence of a year in prison. He was also charged with possession of child pornography and will therefore have to register as a sex offender. The court hopes that this will send a very clear message to the Liangs and anyone else who may look to engage in similar activities. In a statement given to the
New York Times, Attorney General Lanny A. Breuer said “Taking advantage of his special access as a chemist at the F.D.A., Mr. Liang used sensitive inside information to reap illegal profits in the pharmaceutical securities market. “For years, he exploited his position in the agency to make easy money on the stock market. But today’s sentence shows that easy money has consequences. Investors engage in insider trading at their peril.” According to court documents, Mr. Liang told the judge, "I'm terribly sorry for what I've done.” --- On the Net:



06.03.2012 6:14:00

Media_httpiusatodayne_kfgyd

WASHINGTON – The nation's largest drugmakers have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade, but they remain in business with the federal government because they are often the sole suppliers of critical products, records show.

"We're seeing some of the big companies a second and third time," said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services. "The corporate integrity agreement is not sufficient to deter further misconduct."
In addition, the cases are labor- and cost-intensive as the companies fight often for years to avoid an exclusion, Demske said.
To try to change that trend, the government announced in 2010 that, rather than exclude an entire company, investigators would go after individuals within a company. Demske said his organization, the Justice Department and the Food and Drug Administration have come up with some ideas to use within the scope of the rules — such as taking away a company's patent rights as a condition of a settlement. That could begin with cases being investigated now, he said.

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07.03.2012 14:58:00

Pfizer director defends virtual trial after recruitment struggle

By Nick Taylor+

06-Mar-2012

Related topics: Clinical evolution, Clinical Development, Phase III-IV

The head of Pfizer's virtual clinical trial has defended the project after its initial failure to recruit patients raised questions about its viability.

Approval of the trial, which allows patients to take part remotely, was hailed as a big step in the evolution of clinical research. However, since gaining approval the study has met problems.

It didn't recruit”, Miguel Orri, senior director of clinical sciences at Pfizer, said at Partnerships in Clinical Trials in Orlando, Florida. After working towards approval for two years the setback was dispiriting for the Pfizer team.

Orri said problems stemmed from a failure, possibly caused by the team's regulatory focus, to appreciate what patients need. Aspects of the process were “quite complicated and tedious”, Orri said, and Pfizer has learned that patients are still wary putting lots of their health information online.

In response to these realisations Pfizer has revamped the model. A call centre now helps patients through the initial steps and Pfizer is receiving feedback from participants to help shape its plans for the virtual trial model.

Since making the changes Pfizer has seen an “immense inflow of subjects”, Orri said, but the delay means it is behind on its goal of recruiting 600 patients in the US. Despite the setback Pfizer is implementing plans to expand the trial into Europe.

The European trial, REMOTE 2.0, will learn from the mistakes of the US study. Pfizer wants to contract a recruitment vendor to help patients through the initial setup process to end the obstacles experienced in the US.

In a sign that Pfizer is considering the specific needs of the patient population, all participants in the European trial will receive a communication device. The device is like a simplified iPad and the idea is to help patients, particularly older woman from Southern Europe, who spend little time online.

“I don't think we've failed”

In the two years the Pfizer team spent working towards approval it faced internal skepticism, with Orri often being told the project was unfeasible. The struggle to recruit patients could give credence to these views but Orri was quick to defend the trial.

I don't think we've failed. We have created a new online informed consent process I think we can use in many studies in the future”, Orri said. By taking a modular approach to the methods and tools used in REMOTE trial Pfizer can add effective virtual elements to its other clinical research projects.

The US Food and Drug Administration (FDA encouraged this approach by telling Pfizer to validate all tools used in the trial, Orri said. After talking about the trial FDA officials told Pfizer to “milk the study”, Orri said, and validate techniques for future use.

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2012-03-07 08:26:01
Popular soft-drink products contain levels of a chemical that is a known animal carcinogen, according to new chemical analyses. The chemical 4-methylimidazole (4-MI was found in Coca-Cola, Pepsi-Cola, Diet Coke, and Diet Pepsi after an analyses by the Center for Science in the Public Interest (CSPI . CSPI said the carcinogen forms when ammonia or ammonia and sulfates are used to manufacture the "caramel coloring" that gives sodas their distinctive brown colors. The organization asked the Food and Drug Administration (FDA to revoke its authorization for caramel coloring that contains 4-MI, and to change the name of the additive to "ammonia-sulfate process caramel coloring" or "chemically modified caramel coloring." “Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer,” CSPI executive director Michael F. Jacobson said in a
statement. “The coloring is completely cosmetic, adding nothing to the flavor of the product. During the chemical analyses, CSPI collected samples of Coca-Cola, Pepsi-Cola, Diet Coke, Diet Pepsi, Dr Pepper, Diet Dr Pepper, and Whole Foods 365 Cola from Washington D.C.-area stores. The group said Pepsi's products had 145- to 153-micrograms (mcg of 4-MI in two 12-ounce cans, while Coca-Cola had between 142- to 146- mcg per 12 ounces in the samples. The state of California has a 29-microgram limit for 4-MI, and drinks that exceed this number may be required to bear a warning notice. CSPI estimates that Coke and Pepsi products have caused about 15,000 cancers in the U.S. "If companies can make brown food coloring that is carcinogen-free, the industry should use that," Jacobson said. "And industry seems to be moving in that direction. Otherwise, the FDA needs to protect consumers from this risk by banning the coloring.” CSPI said the FDA has an exception for contaminants of food additives if it only causes a risk of one cancer in one million people.  However, even Dr. Pepper and Diet Dr. Pepper having low levels of 4-MI, about 10 mcg per 12 ounces, pose a cancer risk of seven in one million. "Colorings made with the ammonia or ammonia-sulfite process contain carcinogens and don’t belong in the food supply," Jacobson said. "In any event, they shouldn’t be obscured by such an innocuous-sounding name as ‘caramel coloring." --- On the Net:



2012-03-07 05:53:17
The makers of Aeroshot, Breathable Foods Inc has come under fire from the US Food and Drug Administration (FDA . The company labeled the product as both breathable and ingestible, a contradictory combination. The FDA said, “Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied.” The problem comes about because of inconsistency in the labeling of the product. According to the company each shot delivers caffeine and B vitamins in a fine powder that instantly dissolves in the mouth. The agency complained that the company’s website notes the product is not for use for consumers under 18 years of age, while the product label says it is not recommended for people under 12. The FDA complains that the company is targeting both age groups by saying it can be used for studying. Tom Hadfield, Breathable Foods CEO says the product is unintended for people under 18 and they would work with the FDA to come into compliance. The FDA also brings into question Aeroshot’s use as a party enhancer by being mixed with alcohol. Links on the company’s website show articles about using the caffeine product with alcohol. Recently the FDA has been raising awareness about mixing alcohol and caffeine together. It causes people to be in a state of “wide awake drunk” that can lead to alcohol poisoning, car accidents and assaults. In 2010 the company cracked down on Four Loko telling the company to remove the caffeine from their beverage. Aeroshot is not a medication so it did not require FDA approval before being marketed. It is classified as a dietary supplement and requires the manufacturer to be responsible for the products safety. The FDA can only take action against a product if it is deemed unsafe, removing the product from store shelves if it does not fall into safety compliance. Breathable Foods has 15 days to respond to the FDA’s letter and to prove the products safety to the agency. --- On the Net:



2012-03-06 14:39:39
The Obama administration has launched an appeal against the ruling of a U.S. court which found that a mandate requiring tobacco corporations to place large, grisly images as health warnings on cigarette packages violates the First Amendment right to free speech. In his ruling on February 29, D.C.
District Judge Richard Leon found that the attempt by the U.S. Food and Drug Administration (FDA to force cigarette makers to display graphic pictures of blackened lungs, rotten teeth and sickly patients on their products was unconstitutional. Carefully pointing out that the burden of proof lay on the side of the federal regulatory body, Leon stated that: “The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech.” Leon also noted that the proposed warning labels, which aim to deter tobacco use, were exaggeratedly large. He also pointed out that the government already has a variety of more effective and targeted weapons for reducing smoking in its arsenal such as cigarette taxes and labels that contain factual medical information rather than macabre images. The Obama administration announced Monday that it would challenge the court’s decision, filing an appeal Monday with the U.S. Court of Appeals for the District of Columbia Circuit. According to legislation passed in 2009, the FDA is charged with the task of making sure that cigarette packaging is equipped with color warning labels in addition to the well-known written warnings from the Surgeon General. The label must cover 50 percent of both the front and back of the cigarette pack as well as 20 percent of advertisements in magazines. A handful of major tobacco companies challenged the law, which was scheduled to go into effect in September of this year. Tobacco giants R.J. Reynolds, Lorillard Inc., Liggett Group LLC and Commonwealth Brands have alleged that the legislation would essentially force them to advertise against the purchase of their own entirely legal products. --- On the Net:



2012-03-07T19:04:04Z
WEDNESDAY, March 7 (HealthDay News -- Sufaxin (lucinacant has been approved by the U.S. Food and Drug Administration to prevent respiratory distress syndrome, a serious lung condition that affects infants born prematurely.

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