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Agenzia Fides, the missionary press agency of the Vatican, has spoken out against counterfeit drugs
and the approximated 700,000 people expected to die annually due to their pervasiveness.
Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. A large part of these victims are African. The World Health Organization (WHO) estimates that up to 30 percent of the medicines on sale in many African countries are counterfeit and have found that nearly half of the drugs sold in Angola, Burundi, and the Congo are substandard.
In 2003, Interpol conducted a survey on the quality of drugs available in Lagos, sub-Saharan Africa's most populous city and found that 80 percent of the drugs available were fakes. In 2008, more than 80 children in Nigeria died after being given medicine for teething pain that was laced with antifreeze.
Fake medicines can be missing key ingredients, use the wrong ingredient, or have insufficient or too much of the active ingredient. In some cases, use of these medicines can increase drug resistance. When there is not enough of the active ingredient, the drug kills some of the parasites or viruses, but the pathogens that are not killed adapt. As time goes on, even if a patent was to be treated with the correct medication, he or she would not be cured.
Agenzia Fides states, “The development of germs resistant to antibiotics and other treatments is a problem that affects all humanity, not just Africans. It is therefore in the best interest of all concerned that smuggling of counterfeit drugs be fought against.”
Which brings us to the FDA and the future of medical innovation.
A few years ago I had the honor of discussing both topics with Nobel Prize Laureate Joshua Lederberg. Actually, to be accurate, I mostly listened and took notes at the feet of the great man.
When I asked him about FDA's role in 21st century medical science, Dr. Lederberg responded that the real question should be, "Is innovation even possible?"
To that end, have a look at this very interesting and challenging cover story from this week's edition of BioCentury. Titled, "Regulatory Innovation," it makes some keen observations and offers some siginificant food for thought.
Is innovation even possible? Let's hope so.
In an upcoming position paper the Infectious Diseases Society of America suggests that overuse of antibiotics could be controlled via a REMS-like approach – or even an actual REMS.
Interesting idea, because something new must be done. The problem of antibiotic resistance is a real, urgent, and relatively silent public health crisis. For those who rant about the influence of DTC advertising on the doctor/patient dialogue -- it doesn't even hold a candle to a parent's plaintive plea for a prescription when their child has an ear ache.
In the past, FDA has worked with the CDC on consumer education programs such as “Cough, Sniffle, Sneeze – No Antibiotics, Please." But such efforts have met with only modest success (and that’s being generous).
If it takes a REMS to drive the safe and appropriate use of antibiotics, then so be it. Burdensome on docs, yes – but they have nobody to blame but themselves.
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TO BE FOLLOWED BY CMPI'S OWN SEMINAR: TIPS ON HOW TO DATE A DRUG REP
Counterfeit medicines are a real problem – and quantifying that problem is, well, a real problem. How do you estimate criminal activity in ways other than a body count? “Show me the dead Canadians” (as Senator Bernie Sanders is so fond of saying) is not an excuse to do nothing. And purposely derailing the international fight against the false profits of fake medicines via the spanner of "definition" is unconscionable.
Here are four excellent new articles (two from the Wall Street Journal, one from USA Today and the fourth from the Washington Post) that remind us that counterfeit medicines are an important public health issue here at home and around the world.
The first WSJ piece can be found here, the next here, the USA Today story here and the Post’s take here.
While counterfeits are tough to measure, it doesn’t mean that we can ignore the problem. To belittle the problem because we cannot substantiate the volume is unwise. If we wait to count the bodies – we have only ourselves to blame.
I think it is silly to pursue this approach. In the first place, making something prescription does nothing to limit abuse. Indeed, the sharing of prescribed medications is rampant. Secondly, there are other OTC medications that cause many more problems than cough medicines with DXM. That being the case, why not put every OTC that is abused back into prescription or behind the counter. Let's start with aspirin, Vivarin, Red Bull. Why not just ban everything that could possibly lead to adverse events or dependency.
Our poll shows that the first responders and the adults who interact with kids daily (teachers) have bigger issues. Before deciding to require the policing of another medication because it was in the news, the FDA should consider the perspective of those who already have responsibilities for keeping our kids safe. Instead of regulating in this instance the FDA could be educating about the safe and proper use of all medications.
By: Tevi Troy
President Barack Obama announced in his State of the Union address “a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.”
Eight months later, Health and Human Services Secretary Kathleen Sebelius has come out with a report launching the initiative. It does not just call for additional spending, as most federal initiatives seem to do, but for a reconsideration of our life science development process, with a specific call for clearing up bottlenecks that hold up new countermeasures to combat a host of biological threats.
In trying to move the report from paper to policy, the administration may find that some of its most implacable opponents are its staunchest allies, while putative allies may cause the administration heartburn.
“The review repeatedly revealed that aspects of the current regulatory framework and unmet need for regulatory science present both perceived and real barriers for developers seeking to enter the MCM arena,” the report found. In other words, companies looking to create new lifesaving products find the product development process both intimidating and difficult.
To address this, according to the accompanying HHS press release, “HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.”
There is little doubt that bureaucratic hiccups and “bottlenecks,” as the report calls them, make the development process for new medical products — including drugs, vaccines, biologics and devices — longer than it needs to be. It takes about 10 years and $1 billion to bring a new pharmaceutical product to market, making such an investment only available to large or well-funded entities. One longtime career staffer told me while I was HHS deputy secretary that he never understood why industry complained about the Food and Drug Administration until he began working on trying to develop and acquire new countermeasures through BARDA, the Biomedical Advanced Research and Development Authority, which manages Bioshield.
Two years ago, I produced an HHS report detailing strategies to approach bottlenecks in the life science development process, which I shared with the incoming administration.
It is noteworthy, however, that a Democratic administration is coming up with these findings, as criticizing pharmaceutical companies has become a staple Democratic attack. Both John Kerry in 2004 and Barack Obama in 2008 sent barbs their way, and congressional Democrats such as Henry Waxman have long been critical of the companies as well.
Many congressional Democrats, as well as other Pharma critics on the left, will not want to embrace Sebelius’ drive to clear up FDA bottlenecks — and they may be uncomfortable with the funding for the countermeasure enterprise as well.
The new administration initiative calls for $2 billion in funding as “Democrats on Capitol Hill have tried repeatedly to cut funding for the BioShield program to pay for other domestic priorities,” according to Congressional Quarterly’s Julian Pecquet. If the House succeeds in its efforts to cut $2 billion out of this area, the new initiative could be scuttled before it even gets off the ground.
It also is interesting that the report somehow fails to acknowledge the administration that made the greatest strides in encouraging the development of our current countermeasures.
The report notes that “the federal government began work over a decade ago, during the Clinton administration, to develop and stockpile medical countermeasures against biological threats.” Although the report acknowledges Bill Clinton by name, things that happened in the most recent decade are characterized by a sentence saying that “events after Sept. 11, 2001 led to an acceleration of those efforts.” These efforts included, as the report acknowledges, a new smallpox vaccine, the purchase of anthrax antibiotics and vaccine, and countermeasures against botulinum toxin.
Other important developments recognized by the report include the creation of Project Bioshield for development and procurement of countermeasures and the creation of the pandemic flu preparedness plan. Both were major achievements of the Bush administration, as were the creation of a new HHS office of preparedness and response, as well as BARDA itself.
The report’s inartful and passive “after Sept. 11” construction appears to be a kind of Soviet method for referring to actions undertaken by the Bush administration without actually mentioning George W. Bush’s name. The Obama administration may be loathe to acknowledge this, but in calling for clearer regulatory pathways and more funding for developing and acquiring medical countermeasures, it may be angering some key allies, as well as embracing an important part of the Bush legacy.
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.
