Latest Drugwonks' Blog
Yes – it’s the Super Bowl of FDA Part 15 hearings.
For those of you who keep track of such things, the docket for today’s hearing was ranked #1 (as in the most heavily visited) by regulations.gov.
Woot! Woot!
DDMAC panjandrum Tom Abrams did his best not to look like a deer in the headlights. But the crowd was restless. Would he really be able to squeeze 31 presentations into a single day?
Well, when the going gets tough, the tough get going. And so, at the strike of 8AM, Tom Terrific brought the crowd to order and called the first presenter.
First up was Alan Coukell of the Pew Prescription Project. Not an auspicious beginning. He hit a sour note at the top by opining that, “Social media is the same as mass media.” Hmm. He also offered that some space-limited social media apps might not be viable for healthcare social media usage. Alan – don’t give up so easily – and work on those presentation skills.
Next up was the always effervescent John Kamp (representing the 4As and the Coalition for Healthcare Communication.) He picked up the tempo quite considerably by pointing out that the Internet is the “go-to” medium and that the FDA should step forward and set the global “gold standard” for social media regulations. He also wisely pointed out that the FDA should develop its guidelines in collaboration with the FTC.
Then came the Eli Lilly’s lovely and talented Michele Sharp who wisely pointed out that social media must be used to advance the public health. Bravo. She called for guidance both of the written and “executive” varieties, pointing out the dangerous unintended consequences of either too much or too little regulatory direction. She called for a series of FDA public meetings with stakeholder groups. Showing her Hoosier roots, she pointed out that, when it comes to both the Internet and social media, “the barn door is open and it’s never going to be closed.”
Speaker #3 was Boston Scientific’s Tony Blank (speaking on behalf of AdvaMed). He pointed to that organization’s guiding principles for communications and also thanked his young kids for keeping him current on social media. (Word.) He spoke to the issue of “net” impressions (not going there) and how future FDA guidance will have to deal with the ambiguities inherent in dealing with a medium that changes both form and function on a regular basis. His analogy was that the Internet is a “white wall.” Regulated industry writes on that wall – while others come in afterwards and spray graffiti on it. Industry, Tony pointed out, cannot be responsible either for the street art – or for cleaning it up.
Next on the docket was yours truly. It was an awesome experience. My closing comment was, “Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance. My complete testimony can be found at www.drugwonks.com.
Rohit Bhargava (Ogilvy 360 Digital Influence) offered a way to determine manufacturer accountability. He called it the “3Cs” – Creation. Compensation. Collaboration. If there’s a “yes” to any of these three, says Rohit, then a company is responsible for content.
There was, during the course of the day, much conversation about “responsibility.” So before I continue the Day One recap – here’s what the current FDA guidance says on the matter as a point of reference:
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
("Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines:” http://www.fda.gov/cder/guidance/4177dft.pdf.)
Next up was Jeff Francer of PhRMA. He called for guidance to facilitate the use of social media, “the same tools being used today by both the FDA and the White House.” Well Jeff – yes we can! Maybe. He (a la Kamp) also called for risk information to be presented (a la FTC) via “prominently displayed” hyperlinks. And, of course, he discussed PhRMA’s idea for some kind of FDA “Good Housekeeping Seal of Approval.” This set the FDA panelists on edge.
Jeff was followed by John Mack (Pharma Marketing News). John shared an online survey of his readers (354 respondents). One finding was that Pharma companies should all have public social media policies that embrace transparency. Can’t argue with that. He also suggested a special hash tag for any industry-sponsored tweets. And he added another voice to the anti-sidewiki sentiment by declaring, “Google -- tear down this sidewiki!”
End of Panel 1.
Ensuite, ex-FDA attorney and all-around nice guy Arnie Freide. Always keen to point out regulatory precedent, Arnie argued that, since the FDA already created “fair balance and adequate provision” to address risk communications, the agency has the authority to invent a similar procedure for social media – and that no new legal authority was required for the agency to do so. There goes that excuse. He also pointed out, vis-à-vis the issue of sponsor “interest,” that the agency already addresses a very similar concern in its regulation of CME.
Then came James Sandino (the Sandino Group). He told us about social media “back in the day.” That means he worked on Upjohn’s Rogaine – when “social media” meant a 1-800 number. Thanks for the memories. He also said that social media is a healthcare communications “canary in a coal mine.” In other words, it’s a way to determine – swiftly – if a marketing campaign is going to die.
Next was David Adams (Internet Advertising Bureau) who looked like he was waiting on the reception line at the wrong wedding. His big point was that “uncertainty is bad.” Nuff said.
But it was only a momentary lull, because next on the hit parade was everyone’s favorite finger-pointing know-it-all Diana Zuckerman (National Research Center for Women & Families). And she didn’t disappoint. Her first point was to explain why there weren’t more consumer groups on the docket. “They’re too busy on the Hill working for health reform.” Then she commented (relative to the one-click rule) that “one click away is one click too many.” She then talked about how pharmaceutical companies “game” Wikipedia (although she had no evidence to cite). As she commented, “You just don’t know who to trust.” (Translation –- but you can trust me.) And, since using social media is “cheaper” than either broadcast or print, that the FDA should insist that more risk information be provided by marketers. But her best suggestion was that Congress should impose social media user fees. You just can’t make this stuff up.
Then Robert Winder (VuMedia) made the point that “Anonymity is a bad thing on social media.” A point taken up later per the issue of sponsored Google links. But more on that shortly.
Then Wayne Gattinella (WebMD) discussed how social media enhances the doctor/patient relationship and how such engagement leads to better patient outcomes. Now you’re talking.
Final speaker of Panel 2 were the three little maids from WEGO Health (Jack Barrette, Bob Brooks and Marie Connelly). They shared some interesting social media consumer comments. My favorite, “It makes us feel like we’re not yelling into the air.” Been there. Done that.
And at long last lunch.
Panel 3.
First afternoon presenter was Tiffany Mura (Consensus Interactive) who called for the FDA to create a Social Media Advisory Committee. (Isn’t this something that should logically fall to the Risk Communications Adcomm?) She called for social media regulation based on the four principles of speed, responsibility, reasonable effort, and transparency.
Next was Alex Vandevere (Global Prairie Integrated Marketing) who wondered whether we need social media guidelines or guide rails? Not sure what that means – but I like the phrase.
Then Craig Audet (sanofi-aventis) shared that his employer considers itself a healthcare company – not a pharmaceutical company. Très bien! He then wisely suggested that the static elements of social media programs developed by a pharmaceutical company (oops, excuse me, by a healthcare company) be submitted to the agency via Form 2253 (at time of first use) – but that the ensuing user-generated content be allowed to take place in real time. Hard to argue with the realities of the web.
Next was Mark Gaydos, also of s-a, but representing the Social Media Working Group (AZ, s-a, BMS, Millennium, and Amgen). He made a few excellent points. First was that company sites should comply with transparent “terms of use.” That companies should acknowledge and appropriately respond to off-label questions. And that social media sites (such as FaceBook and YouTube) with the interactivity features turned off are not social media.” Nice to have that moose finally on the table.
Mark was followed by David Zinman (Yahoo!) who also made the point that the FDA’s NOVs on sponsored links has resulted in making these ads less transparent to the user. He also discussed an idea to add drop-down ISI (Important Safety Information) boxes to promotional videos – since online viewers aren’t as likely as TV viewers to watch 30 seconds or more of fair balance/adequate provision.
Next up was David Wolin (Waterfront Media) who repeated what others had already said. Not his fault – but it was already getting pretty deep into the docket.
Next was the J&J duo from J&J, Philomena McArthur and Liz Forminard. They discussed the power of social media to enhance health literacy and, as a result, safe use. Clearly music to the FDA panel’s ears. They also made the important point that “clicking through” to information (in this case, risk information) is accepted practice both on Internet and social media sites – and is a whole lot better than the infamous “see our ad in the Saturday Evening Post.” I’m sure Norman Rockwell is turning in his grave. Finally, that new rules to govern social media must be as flexible as the medium itself. (I envisage Tom Abrams as Gumby. Pokey we already have.)
And then came Big Mark Bard (Manhattan Research). People had been quoting his research all day, so it was nice to actually hear from the man himself. A few interesting data points – physicians want pharmaceutical companies to participate online 70% to 30%. Asked the same question, consumers aren’t quite so convinced (35% approve, 25% do not and 40% are unsure). Another interesting factoid is that while physicians and consumers are both online in great numbers –physicians are on with greater frequency (it’s their job) while consumers pop in and out (based on anecdotal need).
End of Panel 3 and most of the seats are still taken.
First speaker of the fourth and final panel was Stan Valencis (Acsys Interactive) who pointed out that 13% of Americans hospitals have social media sites.
Then John Mangano (comScore) shared that there are 1,700 dedicated healthcare websites in the U.S. and that 78% of condition sufferers and 56% of caregivers visit those sites.
That was followed by Fard Johnmar (Envision Solutions) who said, “Internet searchers are like animals on the hunt. They go where the information scent is the strongest.” Pretty feral stuff for an FDA hearing. I wonder what the regulatory analogy is for marking your territory?
Rounding the clubhouse turn was Lawrence Mickelberg (Euro RSCG 4D) whose contribution to the day was this memorable soundbite, “Healthcare begins at search.” Pithy and important.
Coming down the stretch, was W. John Reeves (McCann Healthcare Worldwide) who pointed out that (are you ready for this) digital content on the web has increased 876,000% from 1999 to 2009.
The final presenters of the day were Mary Anne Belliveau and Amy Cowan (Google). They presented a proposal for newly formatted sponsored links that includes a “more information” link and an even more robust version for products with a black box. We’ll see.
And so to bed.
To sleep, perchance to dream … of social media guidance.
A few tidbits:
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Internet can be extremely useful in informing patient discussions with doctors. It can be a helpful tool to empower an individual in their medical decisions. But it is important to remember that not everything online is true. The Internet has made it easier than ever before for charlatans and quacks to spread fear and misinformation. Mark Twain wrote, “Beware of health books. You might die of a misprint.” Having a website does not replace having insight.
Regulated companies mustn’t feel safe behind a social media Maginot Line. Social media is a social movement and using the excuse that healthcare firms can’t engage because “we’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special difference” -- the responsibility of advancing the public health -- that these companies must engage actively and creatively in social media.
As the great social media philosopher, Buffalo Springfield, opined, “There’s something happening here. And what it is ain’t exactly clear.”
One thing that healthcare companies’ worry about is that social media commentators will not factually report the news. A legitimate concern, but is this any different then accurately pitching a story to a reporter at the New York Times and having her miss or misrepresent a clinical data point?
Whether it’s the New York Times or a blog or a social media site for caregivers, information “in” is vetted and controlled. Information “out” is not. Errors and hyperbole are, for better or worse, freedoms of the press.
According to the Pew Internet and American Life Project, 113 million Americans search online for answers to their health questions. Three quarters of these individuals rarely, if ever, check the sources of the material they find
Without the participation of regulated healthcare players, the social media field is left to snake-oil salesmen, Internet drug dealers, unscrupulous trial lawyers and others who operate without almost any constraints whatsoever. Nature abhors a vacuum. It is irresponsible not to correct healthcare information errors. And yet that is precisely the advice being regularly given by regulatory consultants. It is a sad state of affairs indeed that ambiguity on behalf of the FDA has led us to this dangerous state of affairs.
Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience? Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
As F. Scott Fitzgerald wrote, “At 18 our convictions are hills from which we look; at 45 they are caves in which we hide.”
Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance.
According to CDER Office of New Drugs Director John Jenkins, a crucial piece it creating a risk/benefit assessment model is the patient perspective.
"I think it's very important to understand the patients' perspective about how they value the benefits and how they are willing to accept the risk," Jenkins said.
Jenkins continues, "A lot of us are basing these decisions in the abstract. We don't have the disease, we haven't achieved the benefit, and we do not actually have to weigh, personally, that benefit against the risk."
And further, "Regulators and others may not consider those benefits to be very important, but to the patients, they are extremely important and allowed them to go on about their lives.”
Providing people with different therapeutic options is another important aspect of risk-benefit assessment, Jenkins said. "We at FDA consider having a range of choices available to be a very important aspect in the practice of medicine." Even though a drug may not be a best in class, he noted, it may still be the best choice for an individual patient.
There also are various societal expectations about "how we should interpret and apply the standard," he said. He gave the example of when FDA was first criticized for being too slow in approving drugs, and later criticized for being too fast in drug approval, and now it is once again criticized for being too slow.
"So as regulators we have to be aware of the societal expectations of how we interpret our standard and how we make our decisions.”
John Jenkins taking about “societal expectations” within the context of new drug review?
Bravo.
Here is an anecdote about how Medicaid performs today:
Holes in the safety net: Medicaid falls short just as some need it most
As need rises, patients struggle to find doctors who take the insurance plan
By Tom Curry and JoNel Aleccia
msnbc.com
updated 11:13 a.m. ET Aug. 11, 2009
GOSHEN, Ind. - For weeks now, 2-year-old Ashley Soto's hair has been falling out in clumps and bunches.
Doctors at the Maple City Health Care Center, a neighborhood clinic where the toddler's family receives most care, couldn’t diagnose the problem. The child needed to see a specialist, but no local dermatologist would agree to accept Medicaid, the government’s safety net plan. Instead, Antonia Mejorado, 33, has to drive nearly two hours to see a dermatologist willing to treat her daughter's potentially serious illness.
“There is not a doctor around here that takes Medicaid,” said Mejorado, whose husband, Osvaldo Soto, 33, has recently seen his hours cut to almost nothing at a local mechanic shop....
About one in five physicians say they are not accepting any new Medicaid patients, largely because of low payments or delays in reimbursements, according to the Center for Studying Health System Change in Washington, D.C.
‘A lot of things are scary’
Ashley Soto, the 2-year-old with unexplained hair loss, is eligible for Medicaid because she was born in this country. The child’s parents, who are from Mexico, are not. Her mother worries that a serious diagnosis could mean more long days traveling the 75 miles between Goshen and Michigan City, Ind.
“A lot of things are scary — not having a doctor nearby in case something happens to her,” said Mejorado, who is also the mother of three other children ages 17, 14 and 14 months.
http://www.msnbc.msn.com/id/32127373/ns/us_news-the_elkhart_project/
Things are going to get a lot scarier....
From an AEI Report
Medicaid: The Forgotten Issue in Health Reform
By Robert B. Helms
AEI Health Policy Outlook, November 2009
"...the distribution of federal Medicaid expenditures per poor person ranges from a low of $2,014 in Nevada to a high of $7,753 in Maine, an almost fourfold difference. One of the objectives of the original Medicaid legislation was to allow states the flexibility to design a Medicaid program that reflected the preferences of their voters and their willingness to be taxed to support the program. Some states obviously prefer more extensive programs than others, but this choice has been influenced by the availability of federal, open-ended matching. This has had the effect of expanding the program in all states, while expanding it relatively more in higher-income states. The availability of federal funds has also reduced the incentive for the states to design cost-effective programs or to reduce the level of fraud and abuse.
The politics of fixing this conundrum are indeed daunting since it pits one region of the country against another, but to ignore this effect means Medicaid will continue to do a poor job of helping the vast majority of the poor and disabled. Expanding Medicaid eligibility to more adults and to higher-income families with 100 percent federal financing may have a marginal effect to narrow this distribution, but it will not change the basic incentives now built into the system of federal financing."
And efforts to equalize Medicaid spending by "redistributing" resources to the lower cost regions will only hurt the concentration of urban poor in rich states... The same goes for efforts to punish doctors who spend more per patient than 10 percent of the lowest spending docs... (Features in health reform proposals in both houses)
And we are going to increase health care coverage for 50 percent of the uninsured in this fashion?
From the MSNBC report:
"Medicaid reimbursement rates can be as much as 40 percent lower than those for private insurance, according to John Holohan, the director of the Health Policy Research Center at The Urban Institute, a Washington think tank.
Michigan, for example, recently announced a 4 percent cut in payments to doctors, dentists and hospitals who treat Medicaid patients. The move prompted a new exodus of doctors who’ve decided to limit care.
"I love what I do, but I can't keep getting cuts from Medicaid," Dr. John Pfenninger, a family physician in Midland, Mich., told the Associated Press. "It's time to say no. "
Are higher co-pays the answer to controlling medical costs?
NO: Discouraging treatment is shortsighted and leads to more costs.
In the current national health care debate, let’s hope we never hear the words, “As Georgia goes, so goes the nation.”
Since 2005, Georgia politicians have been conducting a dangerous penny-wise, pound-foolish experiment with its state health program by hiking co-pays for brand-name prescription medications.
The results of that policy have been sicker, less productive state employees. These Georgians end up consuming more and costlier health care during the course of their lives, as their neglected conditions worsen.
The lesson here is that higher co-pays discourage patients from getting the treatment they need — especially when they reach upwards of $100.
Just consider what Daniel M. Hartung of Oregon Health & Science University calls the “co-pay effect.”
Professor Hartung and his colleagues analyzed the effect of even a small co-payment — $2 for generic drugs and $3 for brand-name drugs — for those pharmaceuticals that were available to Oregon Medicaid enrollees in 2003.
The co-pay fees were not required for patients who were unable to pay. The researchers examined pharmacy claims data on about 117,000 Medicare enrollees with conditions like depression, schizophrenia, respiratory disease, cardiovascular disease and diabetes.
They found that the patients’ overall use of prescription drugs decreased by about 17 percent after the introduction of the co-pay policy.
It should come as no surprise that any policy that encourages patients to stop taking their prescription drugs is a recipe for disaster.
There is already a growing national trend of Americans not adhering to their prescribed drug regimens.
A study by Wolter Kluwer Health found that fewer and fewer Americans are even bothering to fill their prescriptions.
In fact, during the fourth quarter of 2008, American patients neglected to fill 6.8 percent of their brand-name prescriptions — a 22 percent increase when compared to the previous quarter.
This practice — often known as prescription drug “nonadherence” — can have serious repercussions on a patient’s health.
For example, hypertensive patients who do not take their prescribed medicines as directed suffer 5.4 times as many poor clinical outcomes as those who do.
And poor outcomes are 1.5 times more common for heart disease patients who do not take their meds regularly.
This adds an additional $100 billion to $300 billion in health care costs each year.
The trend has been perpetuated by the fact the Americans with private health insurance have found themselves paying more for prescription drugs in recent years.
Why? Because insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of their prescription drugs costs out of their own pockets.
Many Americans mistakenly believe that this increase in out-of-pocket expenses is the result of higher drug costs. The data reveal otherwise.
In fact, the growth in prescription drug co-payments outpaced the growth rate of prescription drug prices four to one.
It’s easy to see why plans to increase the co-pays for Medicare beneficiaries will also have serious adverse effects on the health of our seniors, as well as on our health care system as a whole.
Unable to afford their prescriptions, many Medicare enrollees will begin treating strict obedience to their drug regimen as a luxury, not a necessity.
As more and more seniors choose to abandon their treatment, health care outcomes will suffer, as prices soar even higher.
Making health care decisions based solely on cost is a losing strategy over the long term for both the state and for the health of its residents.
But maybe those are the kind of shortsighted, budget-driven results you get when cost-over-care bureaucrats run your health plan.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
- Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
- Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
- Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
- Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
- Kristin Davis - Deputy Director, DDMAC - CDER
- David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
- Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
- Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
- Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
- Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
- Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
- Robert Temple - Director, OMP - CDER
- Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH
Yes, the government will be empowered to redistribute health care spending along geographically areas. Doctors in the 20 percent of counties that have the lowest medicare expenditures will get a 5 percent bonus in the House bill. The House bill also propose to revamp hospital and physician fees to equalize geographical payment levels with the goal of forcing down higher spending areas to the lower spending regions. The impact on innovation, access to care and health will be devastating. Such efforts ultimately fail. Both Canada and the UK have substantially increased health care spending (at a faster rate than we have) and still have wide regional disparties in expenditures and outcomes. In the meantime, health outcomes in the US are better than they are in Canada or the UK for cancer and heart disease, the leading causes of death.
Two new articles on the issue of off-label promotion.
The first, courtesy of Bloomberg.com, is far from courteous or unbiased. Consider this quote from Jerry Avorn, a professor at Harvard Medical School and regular critic of the industry:
“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”
Untrue and unfair. That’s a pretty broad brush – but Dr. Avorn has never worried about the unintended consequences of hyperbole.
The Bloomberg article continues, “The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.”
That’s outside of any citation – that’s just the reporter talking. Bad journalism.
And then back to Jerry Avorn:
“It’s an unbearable cost to a system that’s going broke. We can’t even afford to pay for effective, safe therapies.”
Now the article is confusing the issue of off-label promotion with off-label use. And that’s a much clearer articulation of the article’s broader agenda.
The complete Bloomberg article can be found here.
A much better omnibus discussion of off-label promotion can be found in the November issue of Nature Biotechnology. An excerpt:
“… on October 2, Allergan, in Irvine, California, filed a lawsuit against the FDA seeking to challenge off-label regulations. Allergan contends that agency rules stop them from sharing safety information about off-label use of approved drug Botox (Clostridium botulinum toxin). The company contends that Botox is effective for as-yet unapproved uses in spasticity, and given that physicians are already using it for that purpose, it is important to communicate information to reduce the risk of adverse events. Indeed, Allergan claims the regulations violate the right to free speech under the First Amendment of the US Constitution. But it also stands to reason that if the information it seeks to communicate was in the literature, Allergan would not have needed to file the suit.”
The complete Nature Biotechnology article can be found here.
Also quoted in the Bloomberg article newbie FDA employee Peter Lurie, who makes an important point, “Most physicians don’t keep track of FDA-approved uses of drugs.”
All the more reason for a robust and expanded “safe use” program by the FDA.
Label detailing aids anyone?
From today's New York Times:
F.D.A. Fighting False Online Claims About Swine Flu Treatments
You can buy healing gels that “create a barrier between you and the potentially deadly virus now spreading across the globe.” Or “ionic silver” that kills every known pathogen, germ, bacteria, virus or fungus within six minutes. “Spray Swine Flu . . . Gone . . . with ionic silver on your hands,” one ad claims.
Now that the White House has declared swine flu a national emergency, and with the H1N1 vaccine in short supply, many Web sites have been peddling swine flu nostrums.
The Food and Drug Administration has identified 140 different dubious products sold online and has sent letters to 75 manufacturers. It is violation of federal law to market products that claim to prevent or treat H1N1 and that have not been approved by the F.D.A.
The agency has gone after sellers of gloves, inhalers, masks, shampoos, herbal extracts, air fresheners and an array of vitamins that make claims about fighting swine flu. Some of the Web sites were fly-by-night operations that have since closed down.
The complete New York Times story can be found here.
Food for thought for those who continue to foolishy call for risky drug importation schemes.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
