Latest Drugwonks' Blog
Mission creep is a worrisome thing – especially at the FDA.
Awhile back there were some folks at CDRH who believed that the mobiles that you hang over a baby’s crib should be classified as a medical device because they can impact vision development.
No – really.
Fortunately, cooler minds prevailed and sanity won the day.
Today, the issue is whether or not some mobile apps can be considered medical devices. It’s important for many reasons, not the least of which is that over-regulation or the threat of FDA action will slow both the development and adoption of mobile technologies for a variety or urgent public health purposes. Adherence and compliance come to mind as well as safety issues relative to appropriate use/safe use.
To that end, an interesting audio interview in the Burrill Report. It's with Joe Smith, chief medical and science officer for the Gary & Mary West Wireless Health Institute about new draft guidance from the FDA on medical apps, how the agency is approaching these products, and whether this provides the clarity needed to promote investment and innovation in this new world of digital health.
The interview can be found here.
This issue, BTW, is yet another reason why the name of CDRH (the Center for Devices and Radiological Health) needs to change to the Center for Medical Technology.
But FDA advisors are too scared about the possible risks of the drugs to allow diabetics and doctors to see how they work in the real world.
"Several committee members said they could have voted either way.
“I changed my mind about four times in the last 10 seconds,” said Erica H. Brittain, a statistician at the National Institutes of Health who voted no. "
The fate of a new drug should be decided by FDA's Hamlets?
The biggest safety concern was that in clinical trials, patients who got the drug were more likely to develop breast and bladder cancers than those in the control groups.
About 0.4 percent of women taking the drug got breast cancer, compared with 0.1 percent of the women in the control groups. About 0.3 percent of men getting the drug got bladder cancer, compared with about 0.05 percent of men in the control groups.
The numbers were very small, however, making it hard to draw definitive conclusions. Bristol-Myers and AstraZeneca argued that many of the cancers occurred too soon to have been caused by the drugs."
And get this:
"The committee members agreed that more study of the possible cancer risks and other safety questions would be needed. Those who voted no mainly believed that the studies needed to be done before approval, even though that might delay approval by years. "
How many people will die from diabetes related complications because this medicine is not approved in order to organize trials that will likely never resolve the issue?
This is pathetic. The advisory committee members are being haunted by the ghost of Steve Nissen.
Stephen Salzburg, who runs genomic research at the University of Maryland scores a direct hit on the Sun and the quacks whose crap it published in Fighting Pseudoscience
I also wrote a letter to Michael Cross-Barnet who is in charge of op-Eds at the Sun. Here it is in the likely case they don't print my piece:
The Baltimore Sun published two articles that ignore the scientific evidence about the importance and safety of evidence-based vaccination and then make discredited claims about how to make vaccines and immunization safer. It should be ashamed of itself for doing so.
Medical science is not a he-said, she-said process. It is an incremental process of proving and disproving hypothesis based on biological evidence established through experimentation. When facts don’t fit a theory or an assertion, it’s the latter that is wrong.
By giving two pseudo-scientists, Margaret Dunkel and Mark Geier, access to it’s press, the Sun has legitimized misleading and dangerous claims about vaccine safety and about the role vaccines play in causing all sorts of childhood disorders, particularly autism. It perpetuates assertions that contribute to the rise of vaccine preventable diseases such as measles, whooping cough and cervical cancer. And it has legitimized the idea that wild claims about a product causing autism are “science” even if such claims have never been proven scientifically or have been disproven. To the Sun, just raising the possibility of danger is enough to merit publication.
I will not restate the scientific evidence about the significant benefits and incredibly small risks associated with vaccines. One can read Stephen Salzberg’s editorial in Forbes for a concise discussion.
The problem is not with the Geiers and Dunkels of the world who peddle their conspiracy theories and lethal prescriptions for assuring vaccine safety. The problem is with newspapers, new shows and politicians who promote fearmongering.
Would the Sun allow those ‘scholars’ who deny the Holocaust or claim astronauts never landed on the moon access to its editorial page? Both types of conspiracy driven twaddle exist in spite of the facts, not because of them. Yet the Sun, in giving Geier and Dunkel a platform, has given the scientific equivalent of Holocaust denialism legitimacy and renewed strength.
In so doing, it has shamed itself and empowered quacks to endanger the lives of children.
But in a good way.
Learn more about it via an excellent analysis in this week’s edition of BiocCentury which begins thus:
FDA organizational changes and personnel appointments announced last week could help depoliticize the agency’s decision making, increase its understanding of the way industry operates, and, possibly, improve coordination of drug, biologics and device oversight.
The reorganization, which was set in motion by the January departure of Joshua Sharfstein as principal deputy commissioner, also could deepen the bench of managerial talent at an agency that has traditionally valued technical competence over management skills. Radiological Health (CDRH), and the Center for Tobacco Products.
In a memo to FDA staff, Hamburg said one of her goals is to “enable the Office of the Commissioner to better support the agency’s core scientific and regulatory functions, and help tie together programs that share regulatory and scientific foundations.”
The complete article can be found here.
From Sunday’s Washington Post:
David Brooks: The scary and sloppy case for rationing
David Brooks of the New York Times likes to fancy himself as a truth-seeker, bringing social and hard sciences to the masses. But in his Friday column on health care and death, he makes some shocking and inaccurate assertions. Given his coziness with the Obama administration one has to wonder if he is test-driving some Obama administration rationalizations for rationing.
Brooks is enamored of Dudley Clendinen’s “splendid” essay, as he describes, “The Good Short Life.” Brooks thrills to this definition of a life worth living:
Instead of choosing that long, dehumanizing, expensive course, Clendinen has decided to face death as one of life’s “most absorbing thrills and challenges.” He concludes: “When the music stops — when I can’t tie my bow tie, tell a funny story, walk my dog, talk with Whitney, kiss someone special, or tap out lines like this — I’ll know that Life is over. It’s time to be gone.”
Well that “dehumanizing, expensive course” allows millions of Americans who would have died in past years to “kiss someone special.” But is someone confined to a wheelchair (no dog walking) or who needs help dressing not living a life of value? Clendinen, and in turn Brooks, begin down a slippery slope as they decide that, really, is it worth it to keep grandpa around for years if he can’t tie his tie?
Brooks then embarks on a flight of misinformation to suggest we’re wasting much of that money. He finds other useful sources:
As Daniel Callahan and Sherwin B. Nuland point out in an essay in The New Republic called “The Quagmire,” our health care spending and innovation are not leading us toward a limitless extension of a good life. Callahan, a co-founder of the Hastings Center, the bioethics research institution, and Nuland, a retired clinical professor of surgery at Yale, point out that more than a generation after Richard Nixon declared the “War on Cancer” in 1971, we remain far from a cure. Despite recent gains, there is no cure on the horizon for heart disease or stroke. A panel at the National Institutes of Health recently concluded that little progress had been made toward finding ways to delay Alzheimer’s disease.
Much of this is flat-out wrong or misleading. We may not have “cured” all cancers (Brooks is misinformed if he thinks “cancer” is one disease). But survival rates for many types of cancer have soared, especially for breast, prostate and lung cancer. Five-year survival rates for the range of cancers went from 50.1 percent to 65.9 percent in 2000. Peter Pitts of the Center in the Public Interest told me in a phone interview that for many cancers ”early detection and aggressive treatment” can now extend life or result in effective “cures,” that is long-term remission.
A recent report from the Center for Disease and Prevention control explained:
As a result of advances in early detection and treatment, cancer has become a curable disease for some and a chronic illness for others; persons living with a history of cancer are now described as cancer survivors rather than cancer victims . From 1971 to 2001, the number of cancer survivors in the United States increased from 3.0 million to 9.8 million … The number of cancer survivors increased from 9.8 million in 2001 to 11.7 million in 2007. Breast, prostate, and colorectal cancers were the most common types of cancer among survivors, accounting for 51% of diagnoses. As of January 1, 2007, an estimated 64.8% of cancer survivors had lived 5 years after their diagnosis of cancer, and 59.5% of survivors were aged 65 years. Because many cancer survivors live long after diagnosis and the U.S. population is aging, the number of persons living with a history of cancer is expected to continue to increase.
In other words, in just six years the number of cancer survivors increased nearly 20 percent. Interestingly, women and seniors have benefited the most. “Women are more likely to be survivors because cancers among women (e.g., breast or cervical cancer) usually occur at a younger age and can be detected early and treated successfully; in addition, women have a longer life expectancy than men. Among men, a substantial number of cancer survivors had prostate cancer, which is diagnosed more commonly among older men. The large proportion of cancer survivors aged 65 years reflects the increase in cancer risk with age and the fact that more persons with diagnoses of cancer are surviving 5 years.” Put differently, millions more Americans are alive because of progress in cancer research and treatment. I don’t know how one would put a price on the value of lives saved, the contributions those survivors continued to make to society and the children they gave birth to and raised.
Brooks likewise bizarrely claims that there is no “cure” for a heart attack. He surely picked the worse example possible. A heart attack used to be a death sentence or a recipe for permanent convalescence. Now with the advent of beta-blockers, new medical technology and surgical innovations survival rates have risen dramatically. (Researchers, for example, found “rates [of in-hospital mortality] decreased among all patients from 1994 to 2006, falling more markedly in women than men. The steepest drop, 52.9%, occurred among women younger than 55. The mortality rate for men in the same age group decreased by 33.3%.)
Alzheimer’s hasn’t been cured, but drugs to slow the rate of deterioration provide building blocks needed for continued progress. For diabetes the results are stunning. (“People diagnosed with diabetes between 1965 and 1980 lived approximately 15 years longer than those diagnosed between 1950 and 1964 (53.4 years vs. 68.8 years).
Brooks, Pitts says, makes a fundamental error by setting up “cures” as the metric for assessing medical progress. “It is well-established that innovation in health care comes in incremental steps,” he explains. With increasingly personalized treatment made possible by genetic research the type and timing of drugs can be designed for optimal results. If we don’t spend money to make progress that might, for example, slow the rate of Alzheimer’s we’re not going to invest millions in one fell swoop to locate the “cure.” Pitts says, “If you don’t reward innovation,” by funding the painstaking process of step-by-step research we will cease making progress toward long-term survival rates and cures, a result that is not morally or politically acceptable in this country. He observes, “The average American male’s life expectancy has increased by a decade over the last 50 years, largely to due pharmaceuticals. We innovated our way to that.”
Moreover, Brooks ignores diseases such as AIDS, once a death sentence, that is now, albeit by use of expensive drugs, a manageable, chronic disease. Should we not have spent the money? Pitts, noting the dramatic improvements in drugs to treat mental illness, explains that millions of people in the past were never treated at all. “Now people with depression are functioning beautifully.”
Brooks says, “Most of us will still suffer from chronic diseases for years near the end of life, and then die slowly.” True, but the alternative is more dead people.
Brooks in the end doesn’t have the nerve to reach the logical conclusion of his arguments. He declares, “Obviously, we are never going to cut off Alzheimer’s patients and leave them out on a hillside. We are never coercively going to give up on the old and ailing. ” Well, then what is the point of his column? If he can’t stomach these outcomes why shouldn’t we continue to spend substantial sums to improve and elongate life?
Perhaps the point is to rationalize reductions in health-care dollars spent on the elderly, which by gosh is precisely what the Obama administration is trying to pull off with its Independent Advisory Patient Board. Limiting care, conscience free! After all, do all these old people really enjoy living to 90?
By all means we should have the debate over public and private resources. Let’s come up with market solutions that increase competition and reduce cost. Let’s minimize out unnecessary, external costs (e.g. malpractice insurance). And for the record, I am in favor of living wills and allowing those with terminal illnesses to refuse care. But let’s not kid ourselves.
Anyone, for example, who has had an elderly parent, a friend with cancer, or an experience with mental illness knows the difference our health-care system, warts and all, has made in the lives of millions and millions of Americans. Who of us would choose to receive only the medical care available 20 years ago? And, from where I sit, I’m not ready to throw in the towel on my loved ones (or anyone else’s) because they can’t walk the dog.
To that end, it may be that the World Health Organization has come to a crossroads, because in its current guise it is not well suited to help countries facing these challenges.
Back in college, I went to a Transcendental Meditation Center, partly out of genuine interest but mainly because a girl I was interested in was going.
TM was touted as a technique for achieving inner peace back in the day. I remember having to bring some flowers and fruit as an “offering” to a photograph of the Maharishi Yogi, the founder of the TM movement. My mantra instructor (I guess that’s the term) -- a guy in a linen outfit and wire-rimmed glasses – had me kneel in front of the Yogi’s photo while he chanted and threw grains of rice at the picture. Though I was a relatively non-observant Jew then I found the ceremony silly. But not as silly as the claim that if I shared my mantra (ha-yam, not to be confused with Chaim or ham) with anyone it would stop working. And of course my instructor encouraged me to sign up for some lifetime plan of mantra and TM coaching. All that notwithstanding I did find TM helped distract and relax me. But so did taking a nap.
Which leads me to a recent Wall Street Journal op-ed by director David Lynch and TM executive Norman Rosenthal: A Transcendental Cure for Post-Traumatic Stress - Wall Street Journal
Now claiming that TM cures soldiers with PTSD is rather audacious, especially since there is no science to back it up. A five patient study without a control arm is not science, it is a TM retreat. What’s more the authors claim that TM “has been found to reduce blood pressure and decrease the risk of heart attacks and strokes—other conditions in which an overactive fight-or-flight response may play a role. In a similar manner, TM may modulate nervous system responses, thereby allowing affected veterans to relax and leave behind the traumas of war.”
Let’s set aside the fact that the Maharishi University School of Management or TM adherents have mostly conducted the studies supporting TM’s benefits. The research about TM as a medical treatment or “cure” is limited and conflicting. As one review of TM’s cure claims found “ “15 trials comparing relaxation with sham therapy found a non-significant reducing in blood pressure. “ There are only small studies looking at TM’s benefit. Even those that monitor brain function, never establish whether it’s aspects of the TM regimen or TM itself that may help people cope to PTSD, substance abuse and depression. TM is never compared to sleep for instance. Indeed, there are other mindfulness meditation or therapy approaches that have been better studied and have shown to be beneficial.
I believe that TM and other mindfulness modalities do help some people to the extent that they engage in it on a regular basis. But Dr. Rosenthal is plugging a book extolling the value of TM as a cure. He also claims TM is superior to all other forms of mindfulness-based therapies. There is no science to back these claims up. Rosenthal also happens to promote the kind of long term personalized sessions the TM rice thrower wanted me to sign up for when I was in college.
I don’t get how the WSJ not only allowed the publication of what is essentially free advertising to Dr. Rosenthal but also promoted TM as a cure for PTSD. Maybe the editors of the editorial page should meditate on that.
Om.
There is another answer here. Section 801 of the FDCA, which has been revised recently to reflect the global reality, establishes an algorithm for FDA review of imports that priorities scarce resources according to product type, existence (or not) of registration, and other factors. The provision even addresses importation in cases of medical emergency and personal-use importation. It reflects careful attention from Congress – and makes clear that products originating ex-US get heightened scrutiny precisely because they’re not coming from inspected facilities. Asked and answered, people. Or should I say “by the people.”
Did somebody say “drug importation?”
Didn’t think so.
According to the Pew Health Group, the FDA needs much more power to protect the U.S. supply of drugs as more and more are made in other countries.
The new study found that increased outsourcing of manufacturing, a complex and globalized supply chain, and criminals all help to create the potential for counterfeit or substandard drugs to reach patients.
Well, duh – but important to regularly reinforce.
“It is clear the FDA was set up to deal with a domestic industry,” Allan Coukell, the director of medical programs at Pew Health Group, told National Journal. “But drugs are increasingly manufactured globally and are outside of the oversight of the FDA. There is a real need to update legislation to reflect the realities of the industry.”
The FDA is bound by a 1938 law that only gives the agency the authority to inspect products manufactured in the United States. “There’s only so much the FDA can do under the current law,” FDA Office of Compliance Director Deborah Autor said in a statement.
As Peggy Hamburg said at a recent meeting of the Council on Foreign Relations:
* The new reality of food and drug regulation is that it’s global. In fact, it should be a topic for conversation at the next meeting of the G20.
* The recent crises in both food and drug safety will only repeat themselves unless regulatory agencies from around the world work in closer and more regular partnership.
* There is a responsibility on the part of the FDA and other more developed regulatory agencies around the world to help build “regulatory capacity” for those nation’s that want and need assistance.
* Part of a closer working relationship means a more regular and robust sharing of global intelligence on issues of counterfeiting.
* And lastly, “We can’t inspect our way out of this problem."
All good things – progressive things -- but, short of a regulatory Marshall Plan, things that will have to rely (at least initially) on personal relationships between senior officials at various regulatory agencies and a focus on what’s best for global public health writ large is convergent with what’s best for any given nation.
It’s not as easy as it sounds.
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.
