WASHINGTON — The Food and Drug Administration said Tuesday that baby bottles and children’s drinking cups could no longer contain bisphenol A, or BPA, an estrogen-mimicking industrial chemical used in some plastic bottles and food packaging.
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Dumb and Dumber: Hey guys, whoa, big gulps huh? Alright. Well ...
Tomorrow the NYC Department of Health holds hearings on its proposal to ban more than 16 oz servings of sugar sweetened soft drinks.
To paraphrase Abraham Lincoln’s statement about Prohibition: to control human appetite thourhg legislation by making a crime out of something that is not a crime is beyond reason…”
But then again the war against soft drinks and sugar shaping up to be a nutritional Climategate.
Climate change researchers and scientists who do not sing from the global warming hymnal – even if they acknowledge that human activity contributes to changes in our environment – are silenced and sanctioned. They are attacked in public, denied opportunities to publish and participate in conferences and savaged for receiving funding from private companies. The true believers control the message and the policy response to global warming. As Bjorn Lomborg has noted this is leading to” elaborate and expensive actions…to stop global warming that will cost hundreds of billions of dollars, are often based on emotional rather than strictly scientific assumptions, and may very well have little impact on the world's temperature.”
The same thing is going on in the public crusade against sugar and sugar sweetened soft drinks. The attacks that claim sugar is as dangerous as smoking or alcohol are not scientific. Those leading the charge are attacking and silencing anyone who dares to challenge this viewpoint. And it’s leading to policies and actions like the soda ban that limit freedom without having any impact on our health.
The effort to restrict the size of soft drinks consumption flows from an obesity arena that Jeffrey Friedman -- a pioneer in the genetics of obesity – has described as “so political, so rife with misinformation and disinformation.”
As Friedman told the New York Times in 2004, scientific data shows “..that body weight, in animals and humans, is not under conscious control. Body weight, he says, is genetically determined, as tightly regulated as height. Genes control not only how much you eat but also the metabolic rate at which you burn food. “ As Friedman notes, ''People live in the moment. They lose weight over the short term and say that they have exercised willpower.” But over the long term, the body's intrinsic controls win out. And just as willpower cannot make fat people thin, a lack of it does not make thin people fat.”
Indeed, research by the Centers for Disease Control and Prevention shows that the increase in obesity is a result of people who are programmed to gain weight doing so and pulling the average weight of the nation upward. In 1991, 23 percent of Americans fell into the obese category; now 31 percent do, a more than 30 percent increase. But the average weight of the population has increased by just 7 to 10 pounds since 1991.
The same data shows that while “prevalence of obesity in the United States increased during the last decades of the 20th century.. “More recently there appears to have been a slowing of the rate of increase or even a leveling off. The decline is most pronounced in younger adults, primarily women.
Further, previous increases in weight gain are inversely related to the decline in smoking. In fact much of the death associated with obesity is actually related to smoking. So much for Mayor Bloomberg’s assertion that obesity related deaths will soon exceed smoking related mortality.
Last week another study said inactivity is the leading cause of preventable deaths. Set aside the problems of assuming all death is related to inactivity or any other single factor: If inactivity is the leading cause of preventable deaths, can obesity or smoking or anything else be the leading reason too? In fact, several epidemiological studies show that being heavier or even obese is not associated with higher mortality rates. Indeed, a higher BMI in both sexes and WC in men were associated with increased survival in older adults, while a higher WHR or WTR either decreased or did not influence risk of death.
So why focus on sugar or sugar sweetened soft drinks as the biggest public health menace?
Those who do so claim it’s because sugar consumption is out of control and even addictive. (I guess more so than drinking.) But the addiction assertion has little evidence to support it.
And it’s undercut in any event by Department of Agriculture data showing that consumption of sugar and soft drinks has declined over the past decade as fruit, vegetable and fiber consumption as a percent of daily caloric intake has increased. So has the number of people who are not only told by their doctor to exercise but also go out and “just do it.”
New York City is part of this trend. According to data from the Centers for Disease Control and Prevention, New York City kids – across every borough -- follow this national trend. In NYC the adoption of healthy lifestyles by teenagers started in 1997 well before the ban was proposed and well before soda and snack foods were banned from schools. The same goes with exercise. Since 1997, high school students in the city have been watching less television and exercising. Yet under Bloomberg physical education classes have been cut throughout the school system.
http://www.nytimes.com/2012/07/11/education/even-as-schools-battle-obesity-physical-education-is-sidelined.html?pagewanted=all
The ban on soda makes sense only as an emotional response by people whose minds are made up. Otherwise it’s silly. Hence if the soda ban is enacted, you can go to happy hour for NYC 24 oz. tallboys (as well as free jello shots) but not a 20 oz Pepsi. But guess which is a bigger public health problem in the NYC?
Here’s what the NYC Department of Health said about alcohol in NYC: "alcohol-related deaths are among the leading causes of death in NYC; in 2008, an estimated 1,537 NYC adults died of alcohol-related causes. These included deaths from chronic alcohol use, such as alcoholism, and deaths from acute alcohol use, such as binge drinking. Liver disease accounts for one fifth (22%) of all alcohol-related deaths and is the most common chronic cause.” http://www.nyc.gov/html/doh/downloads/pdf/survey/survey-2010alcohol.pdf
Silencing those who disagree with the anti-sugar crusaders will lead to failed polices that distract from more effective solutions and real problems. The soda size ban is just the start down that wrong direction.
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Tomorrow (Tuesday) the New York City Department of Health is holding a public hearing on Mayor Bloomberg’s call to ban sugar-sweetened drinks in portions over 16 ounces from New York City restaurants.
CMPI will be testifying.
In advance of the hearing, we took our roving camera to Central Park on a sunny Saturday to ask New Yorkers what they thought about the Mayor’s initiative.
Short answer – they don’t like it very much.
While recognizing the danger of obesity, those we interviewed were pretty blunt that regulation is a bad idea. They don’t see “more government” as the solution to changing the nutritional habits of the Big Apple.
Sorry Mike.
We will post this video (along with our testimony) shortly.
Bottoms up.
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In "How Fake Cancer Drugs Entered US," the Wall Street Journal reports on how two batches of counterfeit Avastin [bevacizumab] made their way into the US. The Journal specifically details the role played by the Internet pharmacy Canada Drugs.
In an email, FDA spokeswoman Sarah Clark-Lynn said, "The recent counterfeit incidents highlight vulnerabilities in the drug-supply chain and the possible health risk to patients if medical practices are choosing to buy unapproved drugs from a foreign supplier."
Hopefully veep wannabe Tim Pawlenty has been following this story. When he was Governor of Minnesota, Pawlenty promised that his “drugs from Canada” Minnesota RxConnect program would serve some 700,000 people. According to latest statistics, Minnesota RxConnect filled about 138 prescriptions a month. That's for the whole state, population 5,167,101.
That’s a nod to the smarts of the people in the North Star State. Recently Minnesota, state officials observed Canadian Internet pharmacies engaging in dangerous practices.
One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that there is no way to assure safety.
One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.
Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.
One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall "if they wished."
The FDA launched an investigation, confiscating thousands of drug shipments headed for the United States. Some of them were headed for Minnesotans who ordered them over the state's Web site.
When opened, nearly half claimed to be of Canadian origin, but "85 percent of them were from 27 other countries including Iran, Ecuador and China." And 30 of them were counterfeit.
One Minnesota resident discovered that one of his "Canadian" drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific. "I never heard of the place," he said.
If Governor Pawlenty is, indeed, being vetted as a Romney running mate, hopefully he’s being asked about his stance on drug importation.
The full WSJ story can be found here.
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Per the MHRA’s plan to provide early access to some unlicensed products, our spy inside that agency reports that:
MHRA put together a proposal two years ago to allow medicines at the end stage of development trials earlier access to the market. The UK government was not interested in this and kicked it into the long grass. This scheme MHRA proposed at the time would be very like the French ATU scheme which has been in operation for the past ten years or so.
(For more on the French compassionate use program, see here.)
But when last year, the UK government started talking about its "growth agenda,” it decided that early access to new medicines was central to that agenda, it came back to the MHRA for help. We dusted down our previous scheme -- which is now out for consultation.
When the dust clears, we’ll be watching.
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The groups that have failed to turn BPA into a tort law cash cow are seeking to claim victory for a BPA phaseout that companies had in place for years industry... From the New York Times
It would be interesting to read and know more about what companies did to work with chemical companies to develop polymers that had the same benefits of BPA. Maybe one day...
F.D.A. Makes It Official: BPA Can’t Be Used in Baby Bottles and Cups
By SABRINA TAVERNISE
Published: July 17, 2012
Maxine Hicks for The New York Times
Consumer concerns about the safety of BPA led to an industry decision to stop using it in baby bottles and cups for toddlers.
Manufacturers have already stopped using the chemical in baby bottles and sippy cups, and the F.D.A. said that its decision was a response to a request by the American Chemistry Council, the chemical industry’s main trade association, that rules allowing BPA in those products be phased out, in part to boost consumer confidence.
It would be interesting to read and know more about what companies did to work with chemical companies to develop polymers that had the same benefits of BPA. Maybe one day...
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A dynamic proposal from our regulatory couusins at MHRA on early access to life-saving medicines.
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comments on a proposal that would allow early access to unlicensed products for life threatening, chronic, or seriously debilitating conditions without adequate treatment options. MHRA said the program would apply to products with a "positive benefit-risk profile" that have completed Phase III testing. The agency estimates that 1-2 products per year would qualify for the program. MHRA added that in exceptional cases the program may be used for products at an earlier stage of development.
BioCentury reports that the proposal would allow sponsors to request an MHRA early opinion on an unlicensed product for a fee of L29,000 ($45,000). The opinion will be valid for one year and is renewable for L29,000 per year. Sponsors will not be allowed to advertise the products. Local level NHS organizations will be responsible for deciding whether to fund early access products from existing budgets.
MHRA proposed five ways of pricing early access products: conducting a full NICE cost-effectiveness review; setting the same price as that of the therapy for which the unlicensed product directly substitutes; allowing companies to set their own price as long as the impact on the NHS budget is below a predetermined threshold; supplying products for free; or determining prices on a case-by-case basis. Comments are due October 5. MHRA said the program could launch by year end.
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NPR's excellent health blog has a great discussion about Truvada, the HIV retroviral that the FDA just approved as a preventive treatment for a specific sub group of HIV patients: http://www.npr.org/blogs/health/2012/07/17/156868446/deciding-on-truvada-who-should-take-new-hiv-prevention-pill?ps=sh_stcathdl
The debate about the cost is a false one. At a retail price of $13k a year, Truvada is a bargain compared to what we lose and what we spend on treating HIV.
My bet is that insurers will pay for this targeted preventive treatment. As Mark Duggan has shown: previous HIV treatments have reduce Medicaid spending by 16 percent and increase life expectancy by a factor of three.
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From the fine folks at the DIA …
Supreme Court's Health Care Decision was Announced, Now What Does it Mean for the Biopharmaceutical Industry?
To cure your headache over the sometimes confusing decision and more confusing commentary about the Affordable Care Act Supreme Court decision, hear three veteran health law and policy experts explain what to expect in the wake of the decision. They will detail what the case decided, what changed and what didn’t, then explore how it may affect biopharma companies, as well as the political implications and what Capitol Hill might do next as health reform evolves.
Join us on July 26 from 11:00 AM-12:30 PM ET for the Will the PhRMA Deal Stand and What Happens Next? What the Biopharmaceutical Industry Needs to Know in the Wake of the Supreme Court Decision Upholding the Affordable Care Act webinar where you'll hear experts cut through the hype to consider the real effects of the Supreme Court's decision on the drug, device and biopharma industries.
Moderator: John F. Kamp, JD, PhD Executive Director , Coalition for Healthcare Communication
Presenters: Peter J. Pitts, Former FDA Associate Commissioner President, Center for Medicine in the Public Interest
Arnold I. Friede, Former FDA Associate Chief Counsel, Principal, Arnold I. Friede & Associates
Richard Manning, PhD Partner , Bates White Economic Consulting
Agenda and Event Details
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1-215.442.6199
Ellen.Diegel@diahome.org
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Is there no balm in Gilead? Is there no physician there?
-- Jeremiah, viii. 22
Remember when the President said that, under his healthcare reform plan, “If you like your doctor, you can keep your doctor”? Well, that turned out to mean – “If your doctor accepts your new insurance plan, you can keep your doctor.” As my grandmother used to say, “A half truth is a whole lie.”
Now, we must grapple with an even more serious attack on the doctor/patient relationship – essential health benefits. Under the law, insurance policies sold to individuals and small businesses must cover 10 so-called “essential health benefits,” including hospitalization, maternity care and prescription drugs. (See the complete list of benefits here.) But each state will determine how insurance companies cover those benefits in that state.
Or will they?
Representatives Henry Waxman (D-Calif.), Sander Levin (D-Mich.) and George Miller (D-Calif.), ranking members, respectively, on the House Energy and Commerce, Ways and Means and Education and the Workforce Committees, sent a letter to HHS Secretary Kathleen Sebelius (PDF) about the essential health benefits bulletin. The lawmakers contend that when they wrote the Patient Protection and Affordable Care Act, the essential health benefits package was intended as a federal decision, and that one of the primary goals of the healthcare reform law was to create a consistent and comprehensive level of coverage for Americans nationwide.
So, according to these lawmakers, it’s Washington that’s going to decide what’s essential and what’s not – further disempowering a physician’s ability to practice medicine. It’s another step towards one-size-fits-all medicine – the polar opposite of personalized medicine.
This issue of essential health benefits – what they are and who calls the shots – is at the crux of the battle against government-run healthcare.
Late last week, according to BioCentury, a group of 28 Representatives sent a letter to HHS expressing concern about a CMS proposal that may allow insurers to cover only one drug per therapeutic class under the Affordable Care Act's essential health benefits (EHB) plans. The group said a requirement that insurers cover only one drug per therapeutic class would be "overly restrictive," adding that the policy ignores patients' clinical needs and would lead to poorer clinical outcomes and greater healthcare costs.
The group urged HHS to require the plans to cover "all or substantially all" drugs for six therapeutic classes: antidepressants, antipsychotics, anticonvulsants, antiretrovirals, antineoplastics and immunosuppressants. The group noted that products in these classes are not clinically interchangeable, and that the products often have a high discontinuation rate because of lack of efficacy or side effects, requiring patient access to and coverage for multiple products in the same therapeutic class. CMS implemented the same requirement for Medicare Part D in 2006.
While “what” is defined as “essential” is, of course, crucial – the issue of “who” is paramount.
Do you really want Henry Waxman telling your doctor how to practice medicine?
Here is the FDA's statement on it's monitoring of certain employee computers:
The FDA takes very seriously our responsibility to safeguard the confidential information we receive each year from the industries we regulate as well ensuring the ability of employees to voice their concerns.
Shortly after learning that confidential information had been released outside the agency, the FDA initiated monitoring of a small number of FDA employees for whom the agency had evidence suggesting that they might be responsible for the unauthorized disclosure of proprietary information.
The monitoring was limited and intended to determine whether confidential commercial information had been inappropriately released to the public. The agency's monitoring was limited to the government-owned computers of five employees and was only intended to identify the source of the unauthorized disclosures, if possible and to identify any further unauthorized disclosures. These steps were taken because FDA, in order to serve the public health of the American people and respect the proprietary interests of the manufacturers, is statutorily required to protect commercial confidential information and trade secrets. The FDA is legally prohibited from releasing this information without legal authorization.
FDA did not monitor the employees’ use of non-government-owned computers at any time. Neither members of Congress nor their staffs were the focus of monitoring. At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress. Employees have appropriate routes to voice their concerns without disclosing confidential information to the public, and FDA has policies in place to ensure employees are aware of their rights and options.
The FDA's ability to protect and promote public health in the U.S. is tied to our ability to protect confidential information. This allows us to work with industry to ensure the quality of FDA-regulated products and also encourages outside stakeholders to provide us with information that would allow the agency to identify any wrongdoing.
The FDA takes very seriously our responsibility to safeguard the confidential information we receive each year from the industries we regulate as well ensuring the ability of employees to voice their concerns.
Shortly after learning that confidential information had been released outside the agency, the FDA initiated monitoring of a small number of FDA employees for whom the agency had evidence suggesting that they might be responsible for the unauthorized disclosure of proprietary information.
The monitoring was limited and intended to determine whether confidential commercial information had been inappropriately released to the public. The agency's monitoring was limited to the government-owned computers of five employees and was only intended to identify the source of the unauthorized disclosures, if possible and to identify any further unauthorized disclosures. These steps were taken because FDA, in order to serve the public health of the American people and respect the proprietary interests of the manufacturers, is statutorily required to protect commercial confidential information and trade secrets. The FDA is legally prohibited from releasing this information without legal authorization.
FDA did not monitor the employees’ use of non-government-owned computers at any time. Neither members of Congress nor their staffs were the focus of monitoring. At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress. Employees have appropriate routes to voice their concerns without disclosing confidential information to the public, and FDA has policies in place to ensure employees are aware of their rights and options.
The FDA's ability to protect and promote public health in the U.S. is tied to our ability to protect confidential information. This allows us to work with industry to ensure the quality of FDA-regulated products and also encourages outside stakeholders to provide us with information that would allow the agency to identify any wrongdoing.
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.
