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Food (and drugs and cosmetics and tobacco) for Thought

11.26.2009

A new Nature editorial. Pay heed or pay later.

Getting what you pay for

US, 26 Nov 2009 - The US Food and Drug Administration (FDA) is in capable new hands. Its commissioner, Margaret Hamburg, a Harvard-trained physician six months into her tenure, brings to the job both a broad experience in science, public health and biosecurity (see page 406) and an ability to handle multiple, simultaneous demands — a skill she displayed as New York City's youngest health commissioner.

For all her abilities, however, Hamburg is struggling to steer an underpowered ship that is loaded to the gunwales. The 103-year-old agency, based in Silver Spring, Maryland, has never before had so many demands placed on it, nor has its budget ever been so constrained relative to its duties. Between 2001 and 2007, for example, the number of US food-manufacturing plants under the FDA's jurisdiction increased from about 51,000 to more than 65,000, yet the number of staff in its foods programme fell from 3,167 to 2,757. At current inspection rates, any given domestic food company faces a less than one-in-four chance of being inspected once in seven years. And that looks frequent compared with the agency's estimated average inspection rate for foreign manufacturers of medium-risk medical devices: once every 27 years.

It is true that the FDA's funding has been boosted since 1993 by user fees paid by drug- and device-makers. In 2009, such fees amounted to nearly 23% of the agency's $2.7-billion budget. But this influx has, paradoxically, taken the pressure off Congress to fund the many mandates it continues to heap on the agency. For instance, the FDA is expected to monitor the accuracy of direct-to-consumer advertisements by drug companies, and the promotional materials they send to physicians. But in 2008, Congress gave enough money to fund only 55 staff for this job. With some 71,000 industry submissions in 2008, those employees can cope with only a small fraction. Similarly, because drug and device fees are dedicated largely to funding reviews for market approval, other functions at the agency, most notably food safety, have received short shrift.

Calls for more cash inevitably raise red flags in this era of ballooning deficits, but the imbalance between the FDA's means and its responsibilities makes the need inescapable. A bipartisan group including six former FDA commissioners and three former heads of the agency's parent department, the Department of Health and Human Services, has publicly urged Congress to boost the agency's appropriations. So have almost all FDA-regulated industries, including the Grocery Manufacturers Association, the Medical Device Manufacturers Association and most major drug companies, as well as dozens of patient groups.

How much extra money is enough? The FDA's science board was asked the same question by Congress in late 2007 after the board issued a scathing report on the agency's eroding scientific capabilities (see Nature 450, 1143; 2007). To set things right, the board concluded last year, Congress would need to add $450 million to the agency's budget in 2010, and $460 million each year between 2011 and 2013.

The administration of President Barack Obama has asked Congress for a further $295 million for the agency in 2010, which would bring its congressional appropriations to $2.3 billion — less than what is needed, according to the science board's estimates, but "a good start", as Hamburg told Nature earlier this month. Congress should provide at least that much, and make plans to boost that figure in subsequent years.

Historically, it has taken crises to goad legislators into giving the FDA the money and muscle it needs — a notable example being the poisonous cough syrup that killed more than 100 people in 1937, and led to the 1938 enactment of the Federal Food, Drug, and Cosmetic Act, which still forms the basis of the FDA's authority. Congress shouldn't wait for the next crisis.

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Liver ... and Onions

11.25.2009

According to a technical amendment to FDA’s final rule for internal analgesics, acetaminophen products sold in stick packs and sachets must carry warnings about the risk of liver injury by April 29, 2010,.

Warnings on immediate containers such as sachets and stick packs are important because "consumers may routinely remove these packages from the outer carton and, therefore, fail to see the liver injury and stomach bleeding warning if they are only printed on the carton," FDA says in the technical amendment.

By requiring the stick pack/sachet warning, FDA refuses a request from manufacturers.

FDA acknowledged requests that the agency should exempt certain immediate containers from the labeling requirement because of limited space, but disagrees, saying stick packs and sachets have "adequate space to accommodate the required warnings."

Finally, FDA clarifies products with acetaminophen introduced within a year before the final rule's effective date - April 29, 2010 - must include a "see new warnings" flag for at least one year from the launch date.

Products launched after the effective date do not need the new warnings flag.

FDA maintains the rule will not have a "significant economic impact on a substantial number" of businesses.

According to the Tan Sheet, “Acetaminophen marketers could face more burdensome restrictions down the road, including removing certain doses from the market, if FDA follows the advice of an advisory panel convened in April to discuss ways to reduce the risk of hepatotoxicity related to the ingredient.”

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Tough Luck or Tough Love?

11.24.2009

Tough luck, says a front-page commentary in BioCentury. Tough luck getting cutting-edge treatment if you don’t have “the power.”

BioCentury writes:

“In healthcare as in all else, the ability to make important decisions — especially about other people — is at its heart all about power: who has it, how those who have it use it to shape their vision of society, and the effect of those actions on individuals.”

Case-in-point – what happens when the whole becomes more important than the parts therein?

“Two clinical practice recommendations last week — one in the U.K. and one in the U.S. — illustrate the worst of what centralized healthcare can be. Both are based on a vision of society — explicit in the U.K. but still implicit in the U.S. healthcare debate — in which the whole trumps the individual. And both would condemn thousands of patients to death on the grounds that saving their lives is not worth the cost to society as a whole.”

It’s what happens when cost trumps care.

“This kind of gap between benefit to the individual and cost to society will only get worse as more power is centralized in the hands of one or a few payers, and as taxpayer subsidies enable patients to contribute even less to the direct cost of their own care.”

Except, that is, if you’ve got “the power,” a voice, clout.

On Thursday, Senator Barbara Mikulski announced she would introduce an amendment to the Senate healthcare reform bill that “would guarantee women access to mammograms beginning at age 40, and prevent insurance companies from making them unaffordable.”

So much for unbiased, non-political, science-based decisions. It’s about power not about patients.

“Fighting for such patchwork fixes is already the norm in the U.K. and likely to become so in the U.S.: government reviewers will recommend for or against medical interventions based on the cost-benefit to society as a whole, patients and doctors will object, and if their political clout is sufficient, a fix will be made.”

And, the BioCentury commentary concludes:

“Avoiding this quagmire can only be done by going back to the original question — who has power and how is it used — and shifting the answer from government-backed bodies to the patient.”

The complete BioCentury commentary can be found here.

“Ultimately, the only power to which man should aspire is that which he exercises over himself.”

-- Elie Wiesel

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Let history be the judge

11.24.2009

While Senator Harry Reid’s health care bill cleared an initial hurdle over the weekend with the vote to proceed with debate, there is a tough road ahead – and a great deal of compromise needed for passage of a final bill.

The thought of more compromise apparently causes Senator Sherrod Brown (D-OH) profound dismay.

The New York Post reports on Senator Brown’s response to the positions taken by moderate Democratic senators:

All the complaining by centrists prompted Sen. Sherrod Brown (Ohio), one of the Senate's more liberal members, to vent: "I don't want four Democratic senators dictating to the other 56 of us and to the rest of the country -- when the public option has this much support -- that [a public option is] not going to be in it."

But he predicted the quartet of vocal critics would fall in line. "I don't think they want to be on the wrong side of history," he said.

Talk about a totally shameless display of arrogance.

Who is Senator Sherrod Brown to presume he speaks for the future?

Guess what, Senator? Ben Nelson, Joe Lieberman, and Blanche Lincoln represent the citizens of their respective states.

More to the point, their positions are in line with American public opinion.

Rasmussen Reports shows that “just 38% of voters now favor the health care plan proposed by President Obama and congressional Democrats.”

We have a representative democracy and that is how the system operates. If Senator Brown is unable to persuade several moderate Senators of his own party to go along with a certain piece of legislation, then perhaps a little moderation and compromise is in order.

Besides, the federal government seizing control of 1/6 of the US economy should never be easy.

If Senator Brown wants to cut billions from Medicare, impose onerous financial mandates on young Americans, significantly increase the national debt, and relegate all Americans to a lower-quality medical system, then let him say so.

And let history judge him.

Meanwhile, Representative Paul Ryan (R-WI) made this statement on the House floor prior to the passage of Nancy Pelosi’s health care bill.

Watch it. Then ask yourself whose vision of the future is more appealing to you – Senator Brown’s or Rep. Paul Ryan’s.

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Deats don't fail me now

11.23.2009

When Mike Deats talks, people listen – and they should.

Deats (the well-respected head of enforcement at the Medicines and Healthcare Products Regulatory Agency in the United Kingdom) says, “People can be reassured that it is extremely rare to receive counterfeit medicines from either a registered UK pharmacy or from any other legitimate outlet.”

And he’s right. But that doesn’t mean that counterfeit medicines isn’t an important health issue – it is. And the time to deal with it is now – before it becomes a more significant problem, as it already is much of the developing world. There's a lot of money to be made and the penalties for selling counterfeit medicines are small. It's a serious problem that needs to be seriously addressed.

As the Financial Times reports, “While seizures of counterfeit drugs by European customs agents have risen significantly in recent years, the proportion of fake prescription medicines sold through pharmacies and other regulated networks remains modest.” But there’s a lot of money to be made by criminals selling counterfeits over the Internet – and there have been more than a few cases of fakes entering the legitimate pharmaceutical supply chain in the United Kingdom.

And, it's important to note, that many Canadian Internet pharmaceies source their goods from British pharmaceies -- 20% of whose product comes from other "lower cost" parts of Europe.

On a similar note, Mickey Arieli, director of the Israeli Health Ministry's Pharmaceutical Crime Unit, says that “Israelis and former Israelis are behind many of the world's Internet sites that sell counterfeit or other illegal drugs involved in pharmaceutical crimes, providing useless or dangerous products to people who think they are getting the real thing.”

According to Arieli, prescription drugs meant to treat serious diseases like cancer, malaria or attention-deficit hyperactivity disorder were reaching the public, especially via illegal Internet sales.

Most counterfeit drugs, said Arieli, are manufactured in China, but Arieli points to illegal Web sites operated by Israelis or former Israeli residents that expedite the transfer and payment for them.

The time to address counterfeit medicines is now -- before it becomes a public health crisis as it already is in much of the developing world. The profits are high and the criminal penalties are low. And, unless we address the issue -- the problem is only going to get worse.

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The Junk Science of Obamacare

11.20.2009

Maggie Fox nails it. The administration uses selective evidence to save dough on health care and caves in to superstition in shaping vaccine policy.

Read the full article here.

By Maggie Fox, Health and Science Editor Maggie Fox, Health And Science Editor – Fri Nov 20, 12:36 pm ET

WASHINGTON (Reuters) – As U.S. health officials struggle to vaccinate tens of millions of Americans against the pandemic of swine flu, some are looking regretfully at one easy way to instantly double or triple the number of doses available -- by using an immune booster called an adjuvant.

These additives, often as simple as an oil and water mixture, broaden the body's response to a vaccine, reducing the amount of active ingredient called antigen needed.

They are widely used in European flu vaccines as well as in Canada. But not in the United States -- even though the federal government has spent nearly $700 million buying them.

The reason -- people might not trust them.

"If we really do want pregnant women to trust this vaccine or even parents, we have to think about what is acceptable to them," Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said in an interview.

"We have so much vaccine hesitancy in this country," agreed Jeff Levi of the non-profit Trust For America's Health. "To add ... a new element could well have undermined the efficacy of this campaign," Levi told a hearing this week before a Congressional subcommittee.

This frustrates the World Health Organization, which says the global capacity to make influenza vaccines is about 3 billion doses a year -- not enough to cover the population of 6.8 billion people. WHO has hoped rich countries would donate leftover H1N1 vaccine to others.

The U.S. Health and Human Services Department was ready to try adjuvants had the pandemic been worse. H1N1 swine flu has infected an estimated 22 million Americans and killed 3,900, but it so far does not appear to be any deadlier than seasonal influenza.

The worry is that it is affecting younger adults and children instead of the elderly usually targeted by flu, and has the potential to mutate into something more deadly.

"If things had been worse and this would have been a more severe pandemic, we may well have needed to go that way anyway," Levi said.

TRIED AND TRUE

Instead, the United States has stuck with what CDC director Dr. Thomas Frieden has repeatedly called the "tried and true" approach -- the same formulation used in seasonal flu vaccines. Five companies have contracts -- Sanofi-Aventis, CSL, Novartis, AstraZeneca unit MedImmune and GlaxoSmithKline.

Polls show that only about half of Americans plan to be vaccinated against H1N1. Of those who do not, about half say they worry about safety.

Even so, long lines have formed as people try to get the 50 million or so swine flu doses that have rolled out of factories. Drug companies have struggled with an unpredictable virus that does not grow well in eggs, as well as changes to U.S. orders that slowed down packaging.

Studies suggest the supply that is out now could have been tripled.

In September, GlaxoSmithKline found a single shot of its H1N1 vaccine protected 98 percent of volunteers, using an adjuvant and just 5.25 micrograms of antigen. A standard dose without adjuvant takes 15 micrograms of antigen.

Vaccine makers urged Congress this week to help federal agencies find ways to approve the use of adjuvants, and to assure skeptical Americans about their safety.

Dr. Vas Narasimhan, president of Novartis Vaccines USA, noted adjuvants had been licensed for use in Europe for 10 years and tested in 200,000 people.

"Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," Narasimhan told a hearing this week.

He said they may protect better than standard vaccines against viruses that have drifted a little -- the single biggest reason that flu vaccines must be re-formulated every year.

They may also eventually help require less vaccination. "Adjuvanted vaccines have been shown to more broadly prime patients' immune response (up to seven years later), requiring fewer vaccinations to the newly circulating strain," he said.

The National Institute of Allergy and Infectious Diseases is intrigued. Last month it awarded $60 million to researchers and companies to develop new adjuvants.

(Editing by Philip Barbara)

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MedWatchword

11.20.2009

Relative to a social media and the angst-ridden issue of adverse event reporting, here's an idea -- what about an FDA an FDA Facebook page that people can "friend" and through which the FDA can push out information about early safety communications, important safety alerts -- and how to report "official" 4-part adverse events

For more on making MedWatch a better and more user-friendly tool, watch this space.

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What Is Shannon Brownlee Doing At NIH?

11.20.2009

Nothing good. (She is a visiting scholar at the National Institutes of Health, Clinical Center, Department of Bioethics)

First, she is peddling the questionable claim that up to 30 percent of medical care in the US is unnecessary based on a misreading of the Dartmouth Atlas which is already coming under fierce critcism.

Second, she is questioning the efficacy of all flu vaccines.

And now it seems she is using her perch as a visiting scholar to coordinate the writing of a letter to NIH Director Collins by 100 so-called scientists and experts demanding that the NIH study the impact of conflicts of interests on medical research, etc.

And it appears that most of the signatories to the letter are drawn from a list of people that Brownlee and her anti-science collaborator and serial retractor Jeanne Lenzer put together a year ago that they deemed free of pharma influence. Pharma influence perhaps, but not free of trial attorney association or affiliation with Socialist organizations that regard profit of any sort in healthcare immoral. Those too are conflicts or biases -- along with a willingness to abuse one's government position to aid and abet a narrow political agenda -- but those are not to be the subject of any NIH study suggested by the letter writers. Perfectly fine to be free of pharma support... the question is, are they free of conflicts now that they are are petitioning the NIH where the woman who helped organize and coronate them as unconflicted now resides as a visiting ethicist? I guess anything is permissible as long as no money from drug companies is involved. So goes the new morality...

You can compare the signatories to the holier than thou missive and Shannon's circle of purity here..

http://groups.google.com/group/misc.activism.progressive/browse_thread/thread/52ddee237f64e8e4?pli=1

www.pharmedout.org/NIHletter.pdf

Someone ought to investigate Brownlee's role in soliciting the letter, whether she used her time or position at NIH to coordinate the effort. Also, it would be interesting to note if merely writing opinion pieces is what her job entails and whether it is an appropriate use of tax dollars to subsidize an activity that could otherwise be performed in the private sector.

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Asocial Media

11.19.2009

FDA issues warnings to Web sites over drug sales

(AP)

NEW YORK — The Food and Drug Administration said Thursday it issued 22 warning letters to Web site operators over alleged illegal sales of unapproved or misbranded drugs.

The agency said the move caps a weeklong international effort aimed at curbing illegal actions regarding medical products, including sales. In all, the FDA and its partners in the program targeted 136 Web sites that appeared to be illegally selling medical products.

None of the Web sites were for pharmacies in the U.S. or Canada, the agency said.

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The Selective Use of Science in Health Policy

11.18.2009

As I note in my article in the American Spectator today, (spectator.org/archives/2009/11/18/breast-cancer-follies) the US Preventive Services Task Force www.ahrq.gov/CLINIC/uspstfix.htm (bet you didn't know it was effectively a mouthpiece for AHRQ comparative effectiveness research and -- based on AHRQ research -- the final word on what and will be covered under all health care reform bills) has pulled the plug not only on the most reliable tool for breast cancer screening thus far, but also what is becoming an important test for determining whether women are at risk for heart disease.

The rationale given in both cases: What we know about the limits and net benefit of screening for everybody is precise - based on a review of studies that we decided are good enough to review -- and that we don't know enough about new tests and tools to use them.

www.forbes.com/2009/11/16/mammograms-cancer-screening-business-healthcare-mammogram.html

The result? Less screening now and delayed use of newer tools based on scientific advances for years to come.

Follow the logic of the Task Force members:

"Dr. Kerlikowske counters that the new USPTF guidelines are based on a far more detailed and rigorous analysis of the mammography data than has ever been done before. (The USPSTF reviews its guidelines every five years.) "There is new evidence to precisely quantify benefits by age. It didn't exist before," says USPSTF's Diana Petitti. "Those lines of evidence came together to a conclusion that the net benefit of starting earlier rather than later was small."

Precisely quantify benefit? Are we to presume that the benefit is exactly the same for all women without family history of breast cancer? What about those who have not been screened for genetic inclination? And what is net benefit? Sort sounds like a collective benefit to me. Meanwhile, what started all this is the untested assumption that too much screening leads to too much treatment. Is that true? Where is the precision for that number?

The decision to ditch the use of CRP to predict heart disease risk in women of the same ilk. The concern is not public health, but what such tests do to generate "too much" treatment. And again the evidentiary standard is one that ignores the very individual or subpopulation differences necessary to real precision in order to obtain a "net benefit" for a health system. The willful disregard of the JUPITER data as it pertains to women is shocking. Setting aside the real benefits of treating women with high CRP levels with statins in the trial, the study demonstrates that testing for CRP is an important predictor of and precondition to reducing death from heart disease.

online.wsj.com/article/BT-CO-20091117-715499.html

At the very least, the Task Force decisions should factor in the impact on compliance. Ironically, the administration had no problem yanking adjuvant out of H1N1 vaccines to appease Mercury moms and others for whom believing vaccines poison children is a new religion. Or as an administration official said in a recent hearing explaining the mounting delays in vaccine availability, which in turn has lead to doubts, cynicism and apathy about immunization:

If adjuvants were added to the vaccine supply, many of the unadjuvanted doses would need to be taken out of the supply she said.

Also, public confidence in vaccines, in particular vaccines with adjuvant is low, she said. "And we didn't really want to rock the public confidence in a new vaccine with adjuvant."

http://www.medpagetoday.com/Geriatrics/Vaccines/17081

Caving in to unfounded fears is justified to promote public confidence. But what about caving in to cost control concerns and claiming you relied on the best evidence available? Both approaches are driven by politics, not by medical science.

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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.

Latest Drugwonks' Blog

Food (and drugs and cosmetics and tobacco) for Thought

Liver ... and Onions

Tough Luck or Tough Love?

Let history be the judge

Deats don't fail me now

The Junk Science of Obamacare

MedWatchword

What Is Shannon Brownlee Doing At NIH?

Asocial Media

The Selective Use of Science in Health Policy

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