Caffeine to inhale hits market


Source: Newsmap


CAMBRIDGE —  Move over, coffee and Red Bull. A Harvard professor thinks the next big thing will be people inhaling their caffeine from a lipstick-sized tube. Critics say the novel product is not without its risks. 

The product, called AeroShot, went on the market late last month in Massachusetts and New York, and is also available in France. A single unit costs $2.99 at convenience, mom-and-pop, liquor and online stores. 

Biomedical engineering professor David Edwards said AeroShot is safe and does not contain common additives, like taurine, used to amplify the caffeine effect in common energy drinks. Each grey-and-yellow plastic canister contains 100 milligrams of caffeine powder, about the amount in a large cup of coffee, plus B vitamins. 

But Democratic U.S. Sen. Charles Schumer of New York wants the U.S. Food and Drug Administration to review AeroShot, saying he fears it will be used as a club drug so that young people can drink until they drop. Schumer’s national press secretary did not immediately respond to calls for comment. 

FDA spokeswoman Siobhan DeLancey declined to comment, saying the agency will respond directly to Schumer on the matter. 

Edwards said Schumer’s comments are understandable in the context of developments over the last few years, when students looking for a quick and cheap buzz began consuming caffeine-packed alcoholic drinks they dubbed “blackout in a can” because of their potency. But he said AeroShot is not targeting anyone under 18 and it safely delivers caffeine into the mouth, just like coffee. 

“Even with coffee — if you look at the reaction in Europe to coffee when it first appeared — there was quite a bit of hysteria,” he said. “So anything new, there’s always some knee-jerk reaction that makes us believe ‘Well, maybe it’s not safe.’ ” 

Once a user shoots a puff of calorie-free AeroShot into his or her mouth, the lemon-lime powder begins dissolving almost instantly. Each single-use container has up to six puffs. 

“The act of putting it in your mouth is the act of breathing — so it’s sort of surprising and often people the first time they take the AeroShot, they laugh … that it’s kind of a funny way of putting food in your mouth,” said Edwards, who also came up with a breathable chocolate product a few years back. 

Dr. Lisa Ganjhu, a gastroenterologist and internal medicine doctor at New York-based St. Luke‘s-Roosevelt Hospital, said people need to be aware of how much caffeine they are ingesting. 

“You want those 10 cups of coffee, it will probably take you a couple hours to get through all that coffee with all that volume that you are drinking,” Ganjhu said. “With these inhale caffeine canisters you can get that in 10 of those little canisters — so you just puff away and you could be getting all of that within the hour.” 

Even the product packaging warns people not to consume more than three AeroShots per day. 

Northeastern University students who sampled the product recently gave it mixed reviews. 

“This tastes really good and I think it rocks,” student Zack Huang said after puffing onto a free sample before rushing to join a group of friends who were walking away from campus. 

Still, one student was not happy with the taste, echoing sentiment expressed online by some consumers. 

People elsewhere vowed they would never give up their morning coffee. 
“I want to brew it, I want to stir it and I want to drink it slowly as I absorb the caffeine,” said longtime coffee fan Mark Alexander. 

The makers of AeroShot appear to be aware of that sentiment, declaring that the product isn’t about switching away from coffee, but rather making it easier for people with active lifestyles to get their caffeine fix. 

“AeroShot can be used in a variety of settings inconvenient for liquids, such as when you study in the library, board an airplane or get into the car for a long drive,” they say in the section dedicated to frequently asked questions on their website. “It’s easy to take AeroShot with you when you go biking, skiing, curling, or any other activity that consumes energy.” 

AeroShot, manufactured in France and the flagship product of Cambridge-based Breathable Foods Inc., is the product of a conversation that Edwards had with celebrity French chef Thierry Marks over lunch in the summer of 2007. 

“We were discussing what interesting culinary art experiments we might do together and I had the idea that we might breathe foods since I’ve done a lot of work over the last 10 or 15 years on medical aerosols,” Edwards said. 

The first venture Edwards worked on with Harvard students was the breathable chocolate, called Le Whif. Now he’s preparing to promote a product called Le Whaf, which involves putting food and drinks in futuristic-looking glass bowls and turning them into low-calorie clouds of flavor. 

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Massachusetts sues-jj-over-risperdal-marketing Sues J&J Over Risperdal Marketing


Ed Silverman

money-ben-franklinsYet another state has filed a lawsuit alleging that Johnson & Johnson illegally marketed its Risperdal antipsychotic to the detriment of its citizens. This time, Massachusetts alleges J&J promoted the drug to treat elderly dementia and various unapproved uses in children and adolescents. The state also claims J&J failed to disclose serious risks such as the possibility of excessive weight gain, diabetes and, for elderly dementia patients, an increased risk of death.
“Manufacturers should not promote uses of their pharmaceutical products that have not been established to be safe and effective,” Massachusetts Attorney General Coakley says in astatement. “Janssen put profits ahead of patient safety by promoting Risperdal for uses that had not been approved and by failing to disclose serious risks associated with Risperdal’s use.”
The state also charged the health care giant with making misleading and deceptive statements to prescribers about Risperdal safety, especially such side effects as weight gain and developing diabetes; paying docs to participate in “sham consulting programs” that were “thinly disguised” marketing programs touting unapproved uses; and targeting docs who rarely, if ever, prescribed Risperdal for FDA-approved uses which are schizophrenia and bipolar mood disorder (read the lawsuit here).
The lawsuit comes as J&J holds talks to to resolve a raft of litigation and investigations related to Risperdal marketing. Four months ago, J&J set aside an unspecified amount of money to be used to settle some of the litigation. The Office of the Inspector General of the United States Office of Personnel Management, the US Department of Justice, the US Attorney in Philadelphia and Attorneys General of multiple states have been probing off-label Risperdal marketing for years (see this).
Although reports have suggested J&J may wind up settling much of the litigation for $1 billion or so, the tab may be mounting. In June, a South Carolina judge that J&J must pay $327 million for deceptive Risperdal marketing, and last fall, a Louisiana jury ordered J&J to pay $257.7 million in damages for making misleading safety claims (read here), although $73 million in legal fees were later added. In explaining his decision, the South Carolina judge labeled J&J actions “detestable” (look here).
J&J has scored a couple of victories. A lawsuit brought by Pennsylvania officials, who charged J&J hid the risk of diabetes and misled state regulators into paying millions more than they should have for the medicine, was dismissed (see here). And two years ago, a West Virginia judge awarded $3.95 million, after finding J&J misled doctors about risks and benefits, although the state dropped its claim after J&J won an appeal. Nonetheless, the average loss has so far cost about $150 million (four state lawsuits) or roughly $300 million (when considering two actual defeats).
As we have noted previously, J&J will appeal the losses in Louisiana and South Carolina, and could possibly pay much less than the penalties awarded. By suggesting a global deal might total $1 billion or so, the health care giant may try to get the amounts reduced on a proportionate basis, and use the same argument in talks with any state that does not join a settlement. But if more states file lawsuits, the costs could rise. Perhaps the timing of the Massachusetts lawsuit is not a coincidence.
One looming case is scheduled to go to trial this November in Texas. And J&J potentially faces a much bigger liability in that Texas has a much larger population than Louisiana and South Carolina and, therefore, would encounter a heftier payout. This case, by the way, also involves statutory and common law fraud issues that were not raised in the other states. The focus is on the so-called TMAP program that was allegedly designed to boost Risperdal prescriptions by unduly influencing University of Texas professors and state officials to endorse the effort and promote it nationally (read here).

Harvard docs disciplined for conflicts of interest


Published  by Ed Silverman

joseph-biedermanThree years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.
In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”
And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).
The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.
The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.
For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained thisr was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).
doctorsandmoney11And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.
At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).
But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”
“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”
How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.
“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (click on ‘payments to physicians’ here to read the complete statement and the chart showing payments to each doc).
pic thx to jerome kassirer

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