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Dear Colleagues,
I am thrilled to announce the permanent appointment of Elizabeth Dickinson as the Chief Counsel of the Food and Drug Administration, effective Monday, March 12, 2012.
As many of you know, Liz has had a long and distinguished history at the Agency; she joined the Office of the Chief Counsel in 1994. Over the years, Liz has served as legal counsel to the Center for Drug Evaluation and Research and the Office of the Commissioner on innovator and generic drug review issues, orphan drug development, and biosimilars; has implemented pediatric exclusivity and pediatric drug development programs; has worked closely with the Department of Justice on dozens of cases addressing Waxman-Hatch issues and preemption; and has coordinated the development of the Office of the Chief Counsel’s flexible workplace program.
A graduate of the University of Massachusetts and Northeastern University School of Law, Liz is highly regarded by both her internal colleagues and those across the food and drug bar. Over the years, Liz has received numerous awards for distinguished service, leadership and her outstanding legal skills.
Liz has been serving as Acting Chief Counsel since August 2011, and we have been grateful for her hard work and dedication each day that she has been on the job. It is terrific to know that she will be serving the Agency in this role permanently as we move forward. Please join me in congratulating Liz.
Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Two important stories from BioCentury:
FDA to hold hearing on biosimilars guidance
FDA will hold a public hearing on May 11 to discuss three recently published draft guidance documents on biosimilars. FDA said the hearing's purpose is to obtain public comment on the drafts, as well as receive input on topics to be included in the development of future biosimilar policies. The guidance documents, released early last month, indicate the agency hasn't settled some important biosimilars policy questions, including requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics.
EC seeks to reduce duration of reimbursement decisions
The European Commission proposed a Transparency Directive that would reduce the time limits for member states to make pricing and reimbursement decisions for medicinal products. States would be required to issue a decision within 120 days of approval for an innovative drug and within 30 days for a generic. Current regulations require a decision for all drugs within 180 days. Member states that review the relative efficacy of a product via a health technology assessment would still be subject to the 180-day limit.
Under the proposal, member states would be required to designate an enforcement body with the power to award damages and impose penalties for delayed pricing decisions. Member states would also be required to regularly report to the EC on the time required for individual pricing decisions. The new directive is slated to begin implementation in 2014. EC said pricing and reimbursement decisions can take as long as 700 days for new drugs and up to 250 days for generics. The EC began public consultation on the proposed changes last year.
On March 12th, the FDA’s Arthritis Advisory Committee will meet and discuss the anti-nerve growth factor (Anti-NGF), a drug class that is currently under clinical hold because of the threat of joint damage. Clinical trials for Pfizer’s tanezumab were suspended in 2010, at the FDA’s request, when some patients’ arthritis worsened to the point of needing joint replacement – and a class-wide clinical hold followed. (Similar treatments are in early stage development at Johnson & Johnson, Regeneron, Sanofi, Abbott, and AstraZeneca.
Anti-NGF therapies are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. And if the fact that, according to Professor Thomas Schnitzer of Northwestern University, “We’ve had over a hundred years without having a major new pain drug,” isn’t enough – Anti-NGF’s are non-opioids.
FDA has tasked the adcomm to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs and whether the risk/benefit balance for these drugs favors continued development as analgesics.
Why a clinical hold? While a Phase II, 450-patient proof-of-concept study showed that tanezumab relieved knee pain when compared to a placebo, a Phase III study (published in the New England Journal of Medicine) showed 16 patients experienced progressively worsening osteoarthritis associated with a form of bone damage known as necrosis, which required total joint replacements.
In an accompanying NEJM editorial, John Wood a researcher at University College, London and a visiting professor at Baylor College of Medicine (a post funded by Pfizer), wrote the joint failure “was most likely caused by excessive wear and tear in the absence of joint pain. Pain has an important role in the avoidance of self-harm, but chronic inflammatory pain has generally been considered to be wholly undesirable.” The tanezumab study “suggests that a complete quenching of pain in patients with osteoarthritis may not necessarily be a good thing.”
In other words, according to a report in the Wall Street Journal:
“Some researchers are suggesting that an experimental Pfizer drug may have liberated arthritis sufferers to such a degree that they became more physically active — and that the subsequent wear and tear on their joints led to joint replacement surgery.”
The drug made people feel “better than [they] ever felt before, and I have a feeling they just overused their joints,” Nancy Lane, a rheumatologist and bone-health specialist at UC Davis Health System in Sacramento. She suggests the drug could still play a role as long as doctors “counsel patients not to overuse their joints.”
What happens when a drug … works too well? Lane says she has seen this pain-masking situation before, including with the nonsteroidal anti-inflammatory drug (NSAID) indomethacin. “Because this is a new chapter in controlling pain, we didn’t realize we needed to counsel our patients in using their joints that were still diseased. Now we need to figure out how to use it so the risks don’t outweigh the benefits.”
And so the issue of patient education becomes crucial. What happens when a class of drugs is so effective, patients forget they have the underlying condition and behave contrary to their best medical interests? (In plain English – what happens when a therapy is so effective patients over do it and then suffer the consequences?) Hopefully the 3/12 adcomm will spend some quality time discussing this important social science question. Perhaps this issue should be taken up, um, jointly with the agency’s Risk Communications Advisory Committee? Anti-NGF drugs require not only a discussion of benefit/risk – but also the risk of benefit.
Those are, after all, precisely the kind of thorny scientific propositions FDA advisory committees are held to address.
Welcome to 21st century medicine.
Ladies and Gentlemen, start your engines.
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.
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.
