Latest Drugwonks' Blog
Statin risks and benefits: People who take statin medications to lower cholesterol might also lower their risk of depression, a study suggests. That finding might cheer up patients who just learned that the Food and Drug Administration is adding new warnings about elevated blood sugar and memory loss to statin labels.
Epidemiology of this type is to science what Sparknotes is to writing a novel.
Kudos Kim!
http://yourlife.usatoday.com/health/healthyperspective/post/2012-02-29/concussions-in-kids-and-kobe-statin-risks-and-benefits-selenium-and-health-safe-airport-scanners-condoms-that-check-in/637023/1
According to news reports, Sonia Gandhi, the leader of India’s governing Indian National Congress Party, has left the subcontinent for a medical check-up. She made a similar departure from India in August.
Where is she? Thailand? Brazil? Pakistan? Turkey? Or one of the many other nations touting their medical tourism credentials? Top of that list, of course, is India.
We wish Mrs. Gandhi well and assume she is currently being treated in a nation that has an up-to-date pharmacopeia of innovative treatments. That list of countries, it is interesting and disturbing to note, does not include the above-mentioned locations.
Why report on such a study with blaring headlines and warnings and bury all the caveats at the end of the study?
Maybe someone who reads this blog can explain why medical journals publish such garbage and why reporters can't take 5 minutes to look at previous research on the subject?
http://abcnews.go.com/Health/Sleep/sleeping-pills-linked-times-increased-death-risk/story?id=15803687#.T00wPMzu6Uo
Republicans Rock the Airwaves
By Robert M. Goldberg on 2.24.12 @ 6:08AM
http://spectator.org/archives/2012/02/24/republicans-rock-the-airwaves
So why didn't Rick Santorum take advantage to explain his real views on prenatal testing?
The most recent installment of the reality TV series, known as the Republican Presidential Debates, drew more cable viewers than The Jersey Shore or any of the cable channels' tributes to Whitney Houston. Never before have so many Americans been directly engaged in political discourse. (There were as many tweets, Google searches, etc. for the Arizona debate than for any other show on TV the other night!)
If you are like me, you were channeling the candidates and thinking of things they should have said but didn't. Why didn't Romney just say that Romneycare's individual insurance mandate was a mistake just as was Santorum's support for No Child Left Behind? Why not add that much of Romneycare -- individual buying at group rates, reforming Medicaid, and having insurance plans add a health savings account to their offerings -- are things Republicans support.
I hoping CNN's John King would have asked Rick Santorum about his views regarding prenatal testing. Santorum could have restated, without the left's media filter, that he doesn't want to ban contraception or prenatal screening.
Instead, he is concerned that prenatal screening, to detect for so-called birth "defects" such as Down's Syndrome, spina bifida, cystic fibrosis and Fabry's Disease, will be used in combination with abortion to place limits on neonatal care to control health care costs for high risk infants.
He is right to be concerned and talk about it. The health systems of Britain, Canada, the Netherlands and Australia discourage life-sustaining treatment for extremely premature or low birthweight babies. In 2005, the Royal College of Obstetrics and Gynaecology (RCOG) announced that "very premature babies were taking up intensive care space that could be used for healthier babies" and suggested that those born at very low gestations should not be intensively treated but rather allowed to die.
It said such infants were "bed blocking" and that due to better medicines and devices, "[t]here has been a constant need to expand numbers of cots to cover the increasing tendency to try and rescue babies at lower and lower gestations."
A review of neonatal intensive care units in Canada found "the majority of medical staff members do not recommend NICU care for an infant born at 24 weeks' gestation…" The review concludes that in some Canadian NICUs, preterm infants are not considered to be persons and, thus, are not treated in the same way as a larger patient. It doesn't help that Canada has severely limited growth in the number of NICUs. But that's by design. Indeed, to keep their babies alive, Canadian parents go to U.S. hospitals. In recent years hundreds have done so. U.S. doctors try to do what their Canadian colleagues cannot or will not, as in the case of Michelle James. Her doctors in Canada could not halt her labor when it began at 24 weeks and were not optimistic about the viability of her pregnancy. In the U.S., doctors succeeded in stopping labor for three weeks, improving her daughter's ability to survive and avoid a disability.
Could the cold calculus of cost-effectiveness be paired with prenatal screening under Obamacare? It already is.
The Agency for Healthcare Research and Quality and a senior advisor to the Patient-Centered Outcomes Research Institute -- the two agencies responsible for producing comparative effectiveness findings -- are already issuing guidance that would ration care to sick, vulnerable infants based on cost consideration and one-size fits all research.
Jean Slutsky -- who works for both AHRQ and PCORI -- heads up a committee that decides what technologies PCORI will examine. Here's what she and two colleagues said about prenatal screening: "Compelling stories of children who died from very rare metabolic disorders that might have been detected with newer, more expensive equipment have created powerful momentum for expanded screening of newborns. But in an era of constrained budgets, state policymakers need to weigh the benefits and costs of new screening programs against those of other equally important programs. Nonetheless, it remains politically risky to frame a health policy decision as being based primarily on cost or cost-effectiveness." That's compassion for you.
AHRQ and PCORI were established to obscure the fact that health policy decisions based on cost are politically cheap. AHRQ claims that there is no benefit for routine use of inhaled nitrous oxide to oxidate the lungs of pre-term infants. Yet dozens of studies demonstrate that newborns with iNO in combination with continuous airway pressure saves the lives of those with severe respiratory failure and pulmonary hyperplasia. It has been shown to save the lives of infants with premature rupture of the membranes (before 24 weeks of gestation). And it is looking at whether spending so much money on care for at risk babies is "cost-effective."
America spends more on at risk infants than any other nation. More babies that once died because they were too sick or small after birth are alive and part of loving families. We lead the world in life sustaining therapies for newborns. Santorum is standing up against the monstrous moral certainty of Obamacare. Amen to that.
Polly Toynbee, a very left-of-center columnist for the Guardian, writes that, “The NHS was always rationed. What matters is whether it is done rationally or haphazardly, nationally or by postcode, in public or secretly …More treatments are denied without a national or rational debate. A Doctors.net.uk survey of GPs shows most are deeply concerned at rationing by stealth.”
Sound familiar? It should -- it’s a fast-forward look at where we’re going through IPAB. But maybe not.
Tomorrow, at 10AM in Rayburn 2123, the Committee on Energy and Commerce will meet in an open markup session to consider doing away with IPAB via the Medicare Decisions Accountability Act of 2011. AKA H.R. 452, this piece of legislation would repeal Sections 3403 and10320 of PPACA – the sections that established and empowered the IPAB.
And Senator John Cornyn has introduced S. 2118, a bill that would similarly eliminate the Independent Payment Advisory Board.
As we enter into election season, it’s time for our elected representatives to go on the record about their positions on healthcare rationing – of which IPAB is Exhibit A. As Ms. Toynbee writes, Better by far to make these painful choices in the full glare of open public debate.”
Ladies and Gentlemen of Congress -- it's time to stand up and be counted.
According to the World Health Organization, “Counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities.” And, in an editorial, the editors of the Lancet ask, “So what should be done to tackle the growing problem of counterfeit medicines?”
The Lancet makes a strong and straightforward case for action. “The consequences of counterfeit drugs are diverse, as are the solutions, which lie in collective involvement, responsibility, and responses of all interested parties: health professionals, drug regulatory authorities, judicial entities, and drug companies at both national and international levels. Critical to this effort is strengthening of drug regulatory authorities, which should not only be responsible for improving drug standards, but also provide effective recognition of counterfeit drugs and assist other agencies in stopping their trade. This is especially needed in those countries that have either no drug regulation at all or an impaired or corrupted system. Additionally, enactment and enforcement of new laws for prohibiting counterfeit drugs is vital.”
And the editors ask the obvious and troubling question, “So why is there not yet an international fake drug treaty?”
We all know the answer.
The Lancet tells the often uncomfortable and undiplomatic truth that “the Indian and Brazilian Governments and some non-governmental organisations … believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas.”
As Prashant Reddy opined in Spicy IP, “Every time an intellectual property issue is brought up by an international organization in the context of public health we presume that there is an 'imperialist/blood thirsty East India type corporation' conspiring against India. The level of paranoia is simply unbelievable. It is time India started acting like a responsible, confident nation before it decides to torpedo international negotiations. It would also be nice if the Government could start articulating its concerns in the language of public health and not in the language of the generic drug industry.”
Amen.
It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety.
Working together to raise the regulatory performance of all nations will help all nations create sound foundations to address a multitude of quality and safety dilemmas such the manufacturing of biosimilars, the control of API and excipient quality, pharmacovigilance and, yes, even counterfeiting.
And here’s the sharp tip of the Lancet, “The fight against counterfeit drugs must be strengthened without further delay. It needs consensus among all countries and interested parties, and requires wise and bold leadership from WHO. An indispensable goal of the campaign is ensuring the availability of genuine and affordable essential medicines in developing countries.”
Memo to New Delhi and Brasilia – get with the program … or get out of the way.
According to a report in the Wall Street Journal -- About three years before counterfeit copies of Roche Holding AG's cancer drug Avastin surfaced in the U.S., a case in Syria involved fakes of the same drug, showing the company has been grappling with bootlegging of the product for some time.
In 2009, Syrian authorities seized a haul of phony Avastin at a warehouse there, a Roche document shows. The company confirms the case, and acknowledges it has encountered other "individual cases" of counterfeit Avastin in recent years. Until now, the only other known case of Avastin counterfeits, other than the recent U.S. case, was a 2010 incident in Shanghai.
According to officials in law enforcement and the pharmaceutical industry, at least three smugglers were jailed as a result of hauls in Egypt and Syria in 2009 that netted the fake Avastin and other counterfeits drugs. These people said the trio -- who officials said were part of the same counterfeiting network -- were released from Syrian and Egyptian jails last year.
It's unclear whether the Middle East currently produces fake drugs, acts as a transit corridor, or both. Evidence suggests many counterfeits that transit through the Middle East are produced in China. In the same Syrian raids that netted the fake Avastin in 2009, officials found other fake drugs packaged in Chinese-language bags. Authorities also found Chinese-manufactured equipment that the criminals were using to produce fake drugs.
In the 2010 case of counterfeit Avastin that surfaced in Shanghai, 116 patients were given a fake version of the drug. In addition to being used against cancer, Avastin is prescribed to treat an eye disease that causes blindness. The Chinese patients received injections in the eye, and some suffered complications, according to a report on the incident published last year in the New England Journal of Medicine.
Watch the interview here:
The emphasis on sub-group analysis to establish which patients would benefit most from Qnexa -- with an emphasis on collecting data from everyday patients -- reflects both a shift in the Vivus strategy and a change in FDA's outlook. I think going forward a Steve Nissen will not be able to trash drugs of companies that he doesn't work for to the advantage of products from firms that he does with a sloppy meta-analysis. (As as aside, Nissen's use of a meta-analysis to attack Eric Topol's research on the value of using gene tests to select drugs for stenting procedures was recently laughed off and ridiculed.) And companies that want to move a new product to market would do well to seek approval based on those sub-groups where the benefits exceed the risk. And to be able to monitor disease progression and treatment response after market with simple blood tests would advance approval even more. The more risk can be defined and measured at the subgroup or individual level, the less chance anti-innovation forces will have to block new devices and drugs that have clinical utility.
That's what The Critical Path was supposed to do. It sounds like the Qnexa decision was made consistent with that mission.
http://www.fda.gov/.../Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM292317.pdf
How did counterfeit Avastin enter the American drug supply? One reason is that profiteers masquerading as pharmacists are selling unsafe, unregulated, mislabeled, repacked, and co-mingled drugs to unsuspecting consumers – in Europe. “Over there” the cause of this malaise is known as parallel trade. Here at home we call it by another name -- drug importation. Whatever the moniker, its bad medicine. European parallel trade is the weak link in the western world’s supply chain – and the direct cause of our current misadventures with Avastin.
Last year over 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date.
This means that drugs purchased from a British pharmacy to an unknowing American consumer could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by British pharmacies. In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
Surprised about the path of counterfeit Avastin? You shouldn’t be. There is ample evidence linking parallel importation with the growing threat of counterfeits. In August 2004 counterfeit medicines were found in the legitimate British supply chain after a patient complained of a crumbling tablet. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an immediate alert. Only days later, the MHRA had to issue another alert after a different counterfeit medicine was found in Great Britain’s legitimate supply chain. Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.
Danish parallel trader, CareMed, said it was the link in the journey of fake Avastin from Switzerland to Britain. The fake has been traced back as far as Egypt before entering a complex supply chain that ended in California. (Roche does not make Avastin in Egypt.)
CareMed has admitted to sourcing the drug from fully licensed Swiss distributor Hadicon, and the 167 vials of Avastin 400mg were sold from a transit warehouse in Switzerland directly to a transit warehouse in Britain.
"In fact under our distribution license -- for patient safety reasons -- as a distributor, we are not even entitled to open the packages and check that, for example, batch numbers of the vials correspond to the batch numbers of the packages."
CareMed sold the drugs to a "highly valued and experienced customer" in Britain, which informed it at the end of November that the batch numbers on the vials did not match the packages.
The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.”
Facts are stubborn things.
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.
