Shortly after taking the Oath of Office, President Obama made food safety a domestic priority. He called recent national outbreaks of food-borne illnesses a “troubling trend” and a “risk to public health.”

But more than a year later, the Obama administration has yet to fill post of chief food safety official at the Department of Agriculture. He just nominated someone though, Elizabeth Hagen, 40, a person few in the field of food safety had heard of before the announcement.

Hagen, a physician, has never published a word on the subject of food safety. She spent much of her career as a clinician and educator in the field of infectious diseases. She left practice 4 years ago for the USDA, where rose quickly through the department’s Food Safety and Inspection Service.

“Consumer advocates who work closely with [the Department of Agriculture] on policy issues have had limited direct experience with Dr. Hagen,” said the Consumer Federation of America in a release cited by the Washington Post.

Hagen was tapped for the post after the Administration approached at least two other people. Last February for example, it vetted and offered the job to Mike Doyle, a nationally recognized microbiologist. That nomination collapsed after Doyle refused to divest his financial interest in an effort to commercialize a microbial wash for meat.

Whoever fills the position will oversee the safety of meat, poultry and eggs, which comprise 20% of the nation’s food supply.

Last year, there were 13 recalls of beef products contaminated with E. coli. Already this year, there have been six recalls of tainted meats, including an ongoing situation with salami that has sickened hundreds in 40 states.

In response to mounting evidence that bisphenol-A (BPA) is associated with multiple health problems, the FDA will undertake studies of the chemical and implement some regulatory tweaks that help it act quickly if the research uncovers problems.

BPA is a ubiquitous chemical that renders plastic bottles shatterproof. It is also used to coat cans and other containers for food, and is a component of a thousand other consumer goods as well.

The substance leaches from containers into food and can be detected in the urine of 90% of Americans, regardless of age.

Recent studies have linked BPA to cancer, sexual dysfunction, diabetes, heart disease and  abnormal development in fetuses, infants and children.

“We have some concern, which leads us to recommend reasonable steps the public can take to reduce exposure to BPA,” said Joshua Sharfstein, FDA’s deputy commissioner, in a call with reporters.

But the FDA stopped short of an outright ban, saying the data doesn’t justify one. 

Instead, the agency will study BPA and change its classification from a “food additive” to a “food contact material.” The former means manufacturers don’t have to tell the Feds which products contain BPA or in what amounts. The latter requires more disclosure and facilitates a rapid response from the FDA if the stuff is found to pose a risk.

In 2008, Babies R Us and other retailers announced they would no longer stock baby bottles made with BPA. Canada and several US cities and states have already banned BPA from baby bottles.

Until Sharfstein’s announcement, the FDA had maintained that BPA was safe. Its policy was based largely on 2 studies that were funded by the chemical industry. An internal advisory panel criticized this position while calling attention to more than 100 studies that raised doubts about BPA.

Fourteen states have legalized marijuana for medical uses and the Department of Justice has announced it will not prosecute people who use marijuana while under a doctor’s care and in accordance with state rules.

But even as the regulatory landscape clears, the medical issues associated with smoked marijuana remain muddled. Scientists simply don’t know how effective it is as a therapeutic agent. Remarkably, the literature contains fewer than 20 randomized trials of smoked marijuana for all therapeutic indications combined.

Among these, research findings that support using marijuana for neuropathic pain are probably the strongest. For example, in a trial of AIDS patients published in Neurology, scientists found that 52% of those who smoked marijuana reported at least a 30% reduction in pain, as compared with 24% of those who smoked placebo cigarettes.

Smoked marijuana has also been shown to have a modest anti-nausea effect in cancer patients receiving chemotherapy, and to improve appetite and trigger weight gain in HIV-positive patients.

That said, marijuana has not been shown to help patients with a variety of other conditions ranging from epilepsy to immune system disease.

The muddled situation is further complicated by the fact that the FDA doesn’t regulate marijuana. That means, among other things, that the potency of products available in medical-marijuana dispensaries is likely to vary.

“It’s difficult to understand how we can call it medicine if we don’t know what’s in it,” Stephen DeAngelo told the Wall Street Journal. DeAngelo runs a medical-marijuana dispensary in Oakland.

Marijuana, it must be noted, has been associated with palpitations, memory loss, anxiety, psychotic experiences and, yes, an inability to concentrate.

It also carries a risk of physical dependence, though it is not as addictive as nicotine or alcohol. Smoked marijuana may also irritate bronchial tissue, but a study in Cancer Epidemiology, Biomarkers & Prevention found no link between smoking marijuana and lung cancer.

A federal judge has told the FDA to quit blocking the importation of electronic cigarettes from China and ruled the devices should be regulated like tobacco products rather than as drugs or medical devices.

Judge Richard Leon of Federal District Court in Washington issued the order in a lawsuit brought by e-cigarette distributors.

e-Cigarettes are battery-powered tubes that heat liquid nicotine into a vapor which is subsequently inhaled. The devices also add ingredients that give the vapor a taste and smell just like cigarette smoke.

According to e-cigarette distributors, the inhaled mix does not contain cancer-causing chemicals. The FDA argues they have not been proven safe.

Judge Leon ruled that last year’s tobacco legislation gave the FDA power to regulate the contents and marketing claims of e-cigarettes just like traditional tobacco products, but not to ban them.

The FDA released a statement in response: “The public health issues surrounding electronic cigarettes are of serious concern to the FDA. The agency is reviewing Judge Leon’s opinion and will decide the appropriate action to take.”

Ray Story, a VP at Smoking Everywhere, the plaintiff in the suit, claimed the ruling was a victory for people who want a safer cigarette. “The public will have a less harmful alternative to tobacco products,” Story said. “Wherever they’re sold, we are going to be sold.”

Matthew Myers, president of the antismoking advocacy group Campaign for Tobacco-Free Kids, decried the ruling. “These products could serve as a pathway to nicotine addiction for children,” Meyers told the New York Times.

People have estimated e-cigarettes could grow to become a $100 million business nationwide. Traditional cigarette makers are not involved in the e-cigarette business.

You may or may not know by reading the label.

Nearly 20% of the 84,000 chemicals being used commercially in the US—from rust removers to driveway sealants—are being legally kept secret from the public, according to the Environmental Protection Agency.

That gaping problem arose after Congress passed the Toxic Substances Control Act in 1976 to help protect trade secrets but made it rather easy for manufacturers to bypass normal regulatory scrutiny, even when it involves chemicals that could pose harm to humans.

Nearly 95% of the notices for new chemicals received by the Feds in recent years requested the silent treatment. Roughly 700 chemicals are introduced each year to the American market.

Of the nearly 17,000 secret chemicals, most are probably harmless. But chemical producers have disclosed in mandatory reports to the Feds that many pose a “substantial risk” to public health or the environment.

In March, for example, over half of the 65 “substantial risk” reports received by the EPA involved secret chemicals.

151 of the secret chemicals are made in quantities equal to or greater than 1 million tons per year. Ten of them are used in products designed for children, the EPA reports.

Select EPA employees do know the identities of the secret chemicals but they are prohibited from sharing the information with other federal or state officials, emergency responders and the public.

“Even acknowledging what chemical is used or what is made at what facility could convey important information to competitors, and they can start to put the pieces together,” Mike Walls, vice president of the American Chemistry Council told the Washington Post.

The Obama administration wants Congress to make manufacturers prove a chemical should be kept confidential, and wants to allow EPA officials to share that confidential information with state regulators who implement most EPA mandates across the country. Stay tuned.

Ever wonder how safe and reliable Granny’s new pacemaker is? In most cases it turns out nobody really knows, because the quality of the evidence used by the FDA to approve these devices is poor, according to a study published in JAMA last week.

Sanket Dhruva and colleagues from UCSF drew these conclusions after examining the premarket approval process (PMA) for 78 high-risk cardiovascular devices that received FDA approval between January 2000 and December 2007.

PMA is the most stringent FDA review process for medical devices. The scientists found that 65% of the PMA applications for devices were supported by exactly one study.

And overall, the quality of the studies was abysmal. Some failed to provide details like the number of enrolled participants. Only 27% of them were randomized and even less, 14%, were blinded (blinded, randomized, controlled trials represent state-of-the-art scientific research).

The scientists concluded that in general, the FDA’s premarket approval process for cardiovascular devices lacked statistical firepower required to control for bias and hence draw valid conclusions.

The scientists understood that it is more difficult to subject medical devices to blinded studies, since there is no way to produce a “sugar pill” (that is, placebo) for medical devices.

“But we were surprised that so many devices were approved on the basis of a single study,” Dhruva told the Los Angeles Times.

The FDA started approving medical devices in 1976. Recently, there has been a marked increase in the number of cardiovascular devices implanted in Americans.  In 2008, 1.2 million people received stents in the US alone. 350,000 people received pacemakers and 140,000 received implantable cardioverter-defibrillators.

As Washington watchers remain transfixed by the 3-ring circus masquerading as a health reform debate, several Obama appointees have stealthily begun to revitalize the nation’s vast regulatory bureaucracy which had been eviscerated by the Bush administration.

The FDA fired the first shot when it told General Mills it crossed a line with claims that Cheerios lowers cholesterol.

GM was, the FDA said, in effect claiming that Cheerios was a drug, and that it would have to submit clinical trials showing efficacy to the FDA before it could make such assertions.

GM eventually scrubbed the claim from its Web site.

The FDA subsequently went after dietary supplements containing “steroid-like” chemicals and advised consumers to stop using Zicam nasal products after consumers reported it caused them to lose their sense of smell.

The agency knew about both matters during the Bush administration, but didn’t act.

Meanwhile, the new chairman of the Consumer Product Safety Commission, Inez Moore Tenenbaum, has lobbied for a law to cut lead levels in children’s products and drafted new safety standards for ATVs.

And over at the Occupational Safety and Health Administration, acting head Jordan Barab wants to create rules that protect workers from repetitive-motion injuries, which cause 60% percent of all workplace injuries.

“The law says that employers are responsible for workplace safety and health,” he told the Washington Post. “And there’s a new sheriff in town to enforce the law.”

Alas, many of these initiatives are not done deals.  Businesses will argue that they will stifle our nation’s economic recovery. 

Their “argument is going to be that this is going to hurt jobs,” said Michael Livermore, who directs the Institute for the Study of Regulation at NYY Law School.
 
“That has resonance on the Hill and within the public. That’s the one big challenge.”

The FDA has been on a seek and destroy mission against Web sites that distribute products it has not approved for use in the fight against H1N1.

Since May in fact, the agency has warned at least 75 Web sites to stop selling more than 135 products with fraudulent claims of efficacy against H1N1.

The FDA’s latest move in this regard has been to issue a joint warning letter, along with the FTC, to a Web site that markets fraudulent supplements claiming to help prevent spread of the virus.

The letter advises the Web site owners to cease and desist within 48 hours or else face the heavy hand of the law, which could include an injunction by the FTC and seizure of products, an injunction or criminal prosecution by the FDA.

To date, the FDA has identified all sorts of bogus H1N1 products, including:
- A shampoo claiming to protect against H1N1,
- A dietary supplement claiming to protect infants and children from H1N1,
- A supplement claiming to cure H1N1 in 4-8 hours,
- A spray claiming to leave a layer of ionic silver on one’s hands that kills the virus
- Several tests claiming to detect the virus, and
- An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said FDA Commissioner Margaret Hamburg. Such products can “make matters worse by providing consumers with a false sense of protection,” she added.

The FDA has approved 2 anti-viral drugs for treatment and prophylaxis of the 2009 H1N1: Tamiflu and Relenza.  It has also issued Emergency Use Authorizations that extend their approved labeling to additional, specific authorized uses as the pandemic spreads.

Not long ago, FDA deputy commissioner Joshua Sharfstein criticized the process his Agency used to approve ReGen’s Menaflex knee device,  claiming that “extreme” pressure from New Jersey Congressmen had compromised its integrity.

He added that the skullduggery was a factor in prompting his decision to review the FDA’s 510 (k) program, which fast-tracks approval of medical devices by requiring less rigorous clinical testing than the standard process.

“It’s autumn, and change is in the air. This is particularly true for our 510k program,” echoed Donna-Bea Tillman, head of the device evaluation office, in an email to her staff that was obtained by The Wall Street Journal.

The very thought of change to 510k goes over like a lead balloon for device makers like Johnson & Johnson, who warn that tampering with it would end up robbing the public of rapid access to a stream of live-saving, quality improving (not to mention money making) instruments.

J & J spokesperson Carol Goodrich said that 510k streamlines clearance for devices deemed “substantially equivalent” to those on the market, “builds on ever-expanding knowledge,” and accelerates innovation.

Tighter approval standards, she said, “would raise development costs substantially while also creating barriers to market entry that would reduce competition.”

About a third of J & J’s $64 billion in annual world-wide revenues derives from the sale of medical devices and diagnostic equipment.

The FDA’s move was just the latest bad news for the device industry.

Congressional Democrats for example, are pitching a tax on device makers to help pay for  health reform. If passed, the proposal could cost the industry $40 billion over 10 years.

To be sure, the Advanced Medical Technology Association, a lobbying group that represents device makers, is working overtime in Washington to set things straight on both counts.

Why do you suppose physicians frequently prescribe medications for non-FDA approved uses?

A recent survey has confirmed the worst possible reason ends up causing a lot of it: physicians simply don’t know what the FDA has approved, and what it hasn’t.

That’s the discouraging news from a study designed by G. Caleb Alexander and colleagues from the University of Chicago to characterize physicians’ knowledge of the FDA-approved indications of commonly prescribed drugs.

The scientists found in particular that a nationally representative sample of PCPs and psychiatrists knew the correct FDA-approval status for only 55% of drug-indication pairs.

That dismal performance increased to 60% for drugs actually prescribed by the physicians within the last year.

In the study, physicians were asked to complete a questionnaire focusing on 14 common drug-indication pairs, which varied with respect to FDA-approval status and level of supporting evidence. Subjects were asked to indicate whether each pair had FDA approval.

The drug-indication pairs included valproic acid for bipolar disorder and mania, gabapentin for diabetic neuropathy, Lexapro for panic disorder, trazodone for insomnia, Seroquel for dementia with agitation and Effexor for adjustment disorder.

41% of subjects believed that at least one drug-indication pair with uncertain or no supporting evidence had FDA approval, as is the case for the use of Seroquel in patients having dementia and agitation.

Psychiatrists showed better knowledge of FDA approval status than PCPs (66% vs 42%).

“These results indicate an urgent need for effective methods of disseminating information to physicians about the level of evidence supporting off-label drug uses, with specific attention to common off-label uses known to be ineffective or to carry unacceptable risk of harm,” concluded the authors.

The write-up appears in Pharmacoepidemiology and Drug Safety.

The new deputy commissioner of the Food and Drug Administration has criticized his Agency’s approval of ReGen’s Menaflex knee device last December in a report claiming that “extreme” pressure from New Jersey Democratic Congressmen compromised the integrity of the process.

In his report, Joshua Sharfstein asserted that the Congressional heat was “the most extreme (the FDA’s Congressional liaison) had seen. In addition, “the FDA’s acquiescence to (ReGen’s) demands was unprecedented.”

The events undermined the Agency’s ability to “counter the suggestion that lobbying on behalf of ReGen affected the decision,” according to the report which was obtained by the Wall Street Journal.

The Congressmen, Senators Robert Menendez and Frank Lautenberg, and Representatives Frank Pallone Jr. and Steve Rothman apparently encouraged the Agency to hasten its review of New Jersey-based ReGen’s device, which is a collagen meniscus implant designed to guide new tissue growth following surgical repair in patients with tears or loss of meniscus tissue.

Sharfstein added however, that his report does not constitute grounds for Menaflex recipients to panic and that the device remains on the market. The Agency, he said, will begin a review to determine whether that continues to be the case.

The 4 Congressmen countered that their involvement was a simple case of helping a constituent get fair treatment from the FDA.

The case could have far-reaching implications for the medical device industry. It is one reason why the FDA has undertaken a comprehensive review of the 510 (k) program which fast-tracks approval of medical devices by requiring less rigorous clinical testing before approval is granted.

ReGen claims that its product is safe and effective. Former FDA Commissioner Andrew von Eschenbach wasn’t available to comment.

The Food and Drug Administration is mad as hell about illegal products marketed over the Internet claiming to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 (Swine) flu virus.

And it’s not going to take it anymore.

The FDA has warned consumers to stay away from Swine flu products that it has not approved, cleared, or authorized, and beginning in May, it warned more than 50 offending Web site operators to cut it out (see full list here).

Approximately 66% of them did so.

That wasn’t good enough for FDA Commissioner Margaret Hamburg. In a press release last week she said “we are committed to pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, or unauthorized products. We will (continue) our efforts to protect consumers from these fraudulent, potentially dangerous products.”

The bogus products targeted by the FDA include:
- A shampoo claiming to protect against H1N1,
- A dietary supplement claiming to protect infants and children from H1N1,
- A supplement claiming to cure H1N1 in 4-8 hours,
- A spray claiming to leave a layer of ionic silver on one’s hands that killes the virus
- Several tests claiming to detect the virus, and
- An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

The scammers were discovered during Internet sweeps undertaken by the several FDA departments and other agencies.

The FDA has threatened to take civil or criminal enforcement action against vendors that fail to comply with the marching orders.

The FDA will update the labels on 3 commercially-available leukotriene inhibitors to reflect post-marketing research findings that the asthma-fighters can precipitate neuropsychiatric events ranging from agitation to suicidal ideation.

Leukotrienes have become popular options for treating moderate to severe asthma.

They are usually used in conjunction with bronchodilators or inhaled steroid medications.

The new warnings will appear on the labels for Merk’s Singulair, AZ’s Accolate and Zyflo, which is made by Cornerstone Therapeutics.

Singulair dominates the category from a sales standpoint. First approved in 1998, the drug is Merck’s top revenue-producer with $4.3 billion in sales last year. The drug has been approved for both children and adults with asthma and for the treatment of certain allergies. The latter 2 are approved for asthma only.

Leukotrienes are produced by the body in response to inflammatory stimuli such as inhaled allergens.

“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” read the posting on the FDA website.

Neuropsychiatric events that have been linked to leukotriene inhibitors include agitation, aggression, anxiousness, depression, hallucinations, dream abnormalities, insomnia, irritability, restlessness, suicidal ideation, suicide and tremor.

Merck released a statement saying it was “confident in the efficacy and safety of Singulair,” while adding it would revise the label as directed by the FDA.

Neuropsychiatric events other than sleep disorders and insomnia “were not commonly observed” in trial data provided by the drug makers, according to the FDA.

The FDA launched an investigation last year after receiving reports of mood and behavior changes in patients taking Singulair. It asked all 3 drug makers for all available post-marketing information, and made the call after completing that review.

This post first appeared in the Practice Fusion Blog.

Responding to public feedback on a working group’s proposal made last month, the federal HIT Policy Committee has released updated recommendations for defining what is meant by the term “meaningful use” of electronic medical records.

The new recommendations include modifications to the criteria for computerized order entry and a more aggressive implementation time frame for implementing personal health records.

The recommendations now go to the Office of the National Coordinator for Health Information Technology and other branches of HHS, who will use them in developing rules to implement the incentive programs.

The final product should be released beforeyear end.

HITECH legislation states that providers must demonstrate meaningful use of an EMR in order to qualify for bonus payouts under Medicare and Medicaid beginning in 2011.

In an important change designed to ease pressure on providers, the Policy Committee has recommended that its 2011 criteria should apply not just to 2011, but to whatever year a particular provider decides to implement his or her EHR.

Thus if a practitioner decides to go live with an EHR in, say, 2013, he or she will be required to meet 2011 criteria for meaningful use in order to qualify for bonus funding.

The Policy Committee has retained the guideline matrix originally proposed by its working group, while making several modifications to it, most notably with respect to the adoption of CPOE.

Here, the working group’s proposed requirement that providers must use CPOE for “all” orders in 2011 has been diluted to state that 10% of orders “of any type” must be entered by an authorized provider in order to qualify. This will allow pilot CPOE projects and phased implementations to meet the requirement.

The revised criteria also require providers to:
* Implement one clinical decision support rule relevant to a specialty or a high clinical priority;
* Submit claims to payers electronically;
* Check insurance eligibility electronically when possible;
* Provide patients with timely electronic access to their health information;
* Provide patients, upon request, with an electronic copy of their discharge instructions and procedures at the time of discharge; and
* Be able to exchange health information where possible in 2011, and participate in a national health information exchange by 2015. (more…)

This post first appeared on the Practice Fusion blog.

The Federal Trade Commission (FTC) is going ahead with plans to apply its new “Red Flag Rule” regulations to physician practices beginning August 1.

According to the Rule, practices that accept health insurance or permit patients to pay in installment plans must implement written policies and procedures that protect against identity theft before that date, or risk being docked up to $2,500 for each “knowing violation.”

Medical identity theft occurs when a perpetrator uses someone’s identifying information, such as name, Social Security number, insurance coverage data or credit card number, without that person’s knowledge or consent, to obtain or make false claims for medical products or services.

A “red flag” is a pattern, practice or specific account or record activity that indicates possible identity theft.

The American Medical Association has objected to the FTC’s claim that a physician is a “creditor” and hence subject to the Red Flag Rule. It is attempting to delay or prevent implementation of the Rule to physician practices.

The AMA has nevertheless prepared a guidance document and sample policies for physician practices. These can be found here and here.

Contact your local Board of Registration in Medicine or the AMA for more information.

If House leaders have their way, the US food supply chain will soon be more transparent, food facility inspections will be more frequent and food producers will be required to help prevent food-borne illnesses like last fall’s Salmonella outbreak caused by tainted peanuts from Georgia.

Henry Waxman, who chairs the Energy and Commerce Committee and compatriot John Dingell have introduced legislation that would empower the FDA to, among other things, recall tainted food, quarantine suspect food  and impose civil or criminal penalties on violators.

The bill would require growers, manufacturers and food handlers to identify contamination risks, act to prevent them, and document such activities for the Feds. It would also require that private labs used by food manufacturers report to the Feds when they detect pathogens in food products.

“This (legislation) has been needed for decades,” Erik Olson told the Washington Post. Olson, who oversees food and consumer product safety issues at the Pew Charitable Trust, added “we’re still operating under a food and drug law signed by Teddy Roosevelt.”

Consumers including the Big O himself had grown increasingly nervous about food safety following outbreaks of E. coli in California spinach and salmonella in Mexican jalapeno peppers.

But things really hit the fan last fall when numerous deficiencies in the US food handling system were exposed by the peanut caper in which the Peanut Corporation of America shipped Salmonella-laced peanuts which found their way into thousands of products, resulting in 900 illnesses and 9 deaths.

In the aftermath, investigators determined that federal inspectors had not stepped foot inside PCA’s offending Georgia facility for years, and that a private lab used by PCA found contamination on multiple occasions but never reported its findings to regulators.