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Latest News!Written By Comment Count Comment Last Three April 30, 2009
Mario Coluccio
Unhappy with CNN’s Campbell Brown commenting on the flimsy evidence regarding vaccines’ link to autism, actor turned medical expert Jim Carrey has taken to writing commentary on the issue. Writing on The Huffington Post, Carrey states, “If the CDC, the AAP and Ms. Brown insist that our children take twice as many shots as the rest of the western world, we need more independent vaccine research not done by the drug companies selling the vaccines or by organizations under their influence. Studies that cannot be internally suppressed. Answers parents can trust. Perhaps this is what Campbell Brown should be demanding and how the power of the press could better serve the public in the future.” I don’t know what to make of this. I suppose one could chalk it up to Jenny McCarthy’s influence over Carrey. But let us assume that Jim Carrey has invested time in gaining knowledge on this issue and is seriously interested in pursuing the discussion. He writes that we should hear more from those in the medical community not under the influence of vaccine makers. Will a physician with no financial ties to vaccine manufacturers do? In a piece in the Los Angeles Times Dr. Rahul Parikh writes, “By now, most people know that many parents are refusing to vaccinate their children because they're scared that vaccines cause autism. They've heard the public rants of people who form a small but vocal and well-financed minority in the autism community and been frightened by them. Actress Jenny McCarthy, for example, who has had her share of appearances on "Larry King Live" and "The Oprah Winfrey Show," has screamed (literally) that she would rather children get measles than autism. At best, that's a false choice; at worst, it's a sick, horrible wish for her or anybody else's child.” Autism is undoubtedly a terrible affliction – and we all sympathize with the parents of autistic children. But it is simply unforgivable for Jim Carrey and others to continue scaring parents out of their minds with abandon. That said, Dr. Kevin Pho of KevinMD correctly notes that the medical community’s time would be better spent avoiding getting bogged down in a debate with the anti-vaccine zealots and instead work on improving the message to parents and the public about the benefits of vaccines. Dr. Pho writes, “no amount of data will convince those who refuse vaccines.” He advises, “Rather than fighting a reactionary battle with them, it's wiser to spend money proactively promoting the benefits of vaccines, or even better, convincing parents what will happen if more begin to refuse them for their kids.” Hear, hear! -
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April 30, 2009
Peter Pitts
From the pages of Forbes ...
How To Maintain FDA Standards Don't follow Marcia Angell's recommendations. Bruce Gingles and Thomas P. Stossel, For over 100 years, the U.S. Food and Drug Administration has balanced bringing important new medical products to patients with ensuring their safety. No drug or device is 100% safe, but physicians have steadily obtained ever more effective tools that increase patient longevity and quality of life. Still, critics we dub "pharma-scolds" depict the FDA as a stooge of medical-products manufacturers and demand that the agency develop a more adversarial relationship with the pharmaceutical industry. One inveterate fault-finder, whose opinion is often sought by credulous audiences, is Marcia Angell, former acting editor in chief of the New England Journal of Medicine and author of The Truth About the Drug Companies. In an April 6 piece in The Boston Globe, Angell made sweeping recommendations that, if enacted, will set back patient care. First, Angell wants to eliminate the "user fees" drug companies currently pay the FDA to evaluate their products. Such fees, she argues, confer "employee" status on the agency. But these companies have no input into the FDA's final decision to approve or deny new drug applications. Substantial research shows that user fees benefit patients by allowing the agency to hire additional staff to process new drug applications in a timely manner. And many other federal agencies--even the post office--supplement their budgets with user fees. Taxpayers clawing their way out of an economic recession should appreciate that the industry pays in part for its own regulation. Next, Angell wants the FDA to exclude industry consultants from advisory committees on new products. But evidence shows that the most productive scholars have industry relationships, and that such relationships have no effect on their recommendations for drug approval. It seems Angell would rather have the FDA get less useful advice than turn to experts who work with companies to develop life-saving products. Angell also wants direct-to-consumer advertising for new products banned for three years after they're launched, limiting market penetration so that side effects not detected by pre-approval trials will affect fewer patients. But since rare complications emerge only after widespread product use, her recommendation is illogical. Banning this advertising, as Angell suggests, would mainly serve to keep useful products from patients who need them. This brings us to Angell's worst idea: discouraging "me-too" products--drugs developed as variants of new medicines--based on the incorrect presumption that such products increase costs without adding clinical value. Once a new drug is approved, Angell suggests, no more drugs should be approved for the same general purpose unless it is judged superior to the first product in head-to-head clinical trials. But Angell fails to understand that most useful innovation is evolutionary, not revolutionary. Tweaking antibiotics, for example, counteracts the penchant of disease-causing microbes to develop resistance to them. Radically curtailing second-generation products makes neither medical nor economic sense and borders on murderous absurdity. The introduction of "me-too" products by multiple companies facilitates testing of the products in different clinical indications, expanding their versatility and benefit to patient. Competition among brand products reduces prices, and sales of incrementally beneficial products provide the revenues to support the research and development of the occasional breakthrough drug. If the first cholesterol-lowering drug (called a statin) for preventing heart attacks had been not Merck's ( MRK - news - people ) Mevacor, but Bayer's ( BAY - news - people ) Baycol--which was later shown to have potentially fatal side effects--and the FDA had delayed the introduction of new statins because it was waiting for evidence from head-to-head trials, patients who needed to cholesterol reduction and had only Baycol available would have been without any alternative. As another example, lanidomide is not materially more effective than thalidomide (from which it is derived) as a treatment for the disease multiple myeloma, but it lacks thalidomide's side effects. Angell also wants the FDA to exclude surrogate measurements--like cholesterol, which correlates with heart attack risk--as criteria for approval of second-generation products, because such measurements don't always predict clinical outcomes. Instead, Angell thinks companies should conduct expensive trials to document clinical benefits. However, surrogate values are frequently predictive. Scientists use surrogate markers to make reasonable predictions about actual outcomes in patients--giving patients faster access to new treatments. FDA approved both thalidomide and lanidomide based on surrogate measurements. Abandoning them would make a perfect enemy of the good. Last but not least, Angell wants to accelerate FDA approval of generic products, alleging that the "FDA takes roughly twice as long to approve them as to approve brand-name drugs." Generics are the ultimate "me-too" products--they're just cheaper copies of older drugs. Generics are fine, but Angell draws a false comparison. User fees do shorten the time between the filing of a new drug application and an FDA decision; pre-application development time for innovative products is far longer than for generics. A better metric is to compare actual numbers of new drug and generic drug approvals: In 2008, the FDA approved 21 innovator drugs and 90 first-time generics. In short, Angell's calls for reform would lead to decreased patient access to lifesaving new products, higher drug prices and less competition between pharmaceutical companies. As public policy, that's a prescription for bad health. Bruce Gingles is vice president of Cook Group, a medical device company. Thomas P. Stossel is a professor of medicine at Harvard University and a senior fellow at the Manhattan Institute for Policy Research. -
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April 29, 2009
Dr. Robert Goldberg
Still trying to get my mind around the IOM conflict of interest document. I am sure it is because I am not smart enough, as the report implies, to discern if my doctor is a total degenerate because he is unconsciously being manipulated to prescribe a certain product because of the free lunches that were handed out. Or as the IOM study puts it, it is too bad if I want to judge my doctor or a scientist on the quality of his or her work alone. Oh no. You see, " Here again the problem is that many people affected by professional decisions are not in a position to judge the validity of those decisions. In addition, those who are competent to judge may not be able to do so until after the damage has occurred. "
Note that the IOM report never specifies or demonstrates through research what damage has occured. And note that it presupposes that the great unwashed are too stupid to figure out that it is being duped to able to judge outcomes. Incredible. So much for evidence based medicine. Meanwhile, "policies designed to reduce conflicts of interest and mitigate their impact provide an important foundation for public confidence in medical professionals and institutions." That should apply to every financial conflict. To the extent that most of the money and power in the health care system comes from government and involve hospital services that do NOT include devices and rugs. I have only suggested that the focus also be on the abuse of government's role in shaping research and clinical decisions and creating appropriate transparent firewalls between insurers, hospital and physicians so that doctors can be trusted to do what's best for the patient. Finally there is the presumption that commercialization is inherently corrupting and that therefore information disseminated with support from commercial sources should be banned or disregarded without regard to scientific or intellectual merit. Perhaps I read too much into the IOM report. But to the extent that it calls for all measures to limit and eliminate such relationships while failing to disclose similar cozy connections of financing and self-referencing that created the conflict of interest issue, supported the work of the IOM, paid for it's consultants directly and indirectly all while having a media complicit in ignoring these connections, the end result is not objectivity but bias pure and simple. There may be merit in some recommendation or another in the IOM report. However the ultimate to goal is to enforce limits on science and medical practice that the authors would not impose on itself or many other interests who would profit from a decline in the rate of the introduction of new products. -
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April 29, 2009
Dr. Robert Goldberg
The Obama administration's response -- even absent top HHS and FDA officials -- has been fairly good. A tribute both to the work of civil servants and sciences in government and to the planning of previous administration. Tevi Troy, my friend and fellow Yankee fan who had a hand in crafting the game plan that is now being used by Team Obama provided his take in yesterday's WSJ. If only Tevi could provide two innings of left handed relief for the Yanks.
How Bush Prepared for the OutbreakSwine flu has presented the Obama administration with its first major public-health crisis. Fortunately for the Obama team, the Bush administration developed new tools that will prove critical in meeting this challenge. Under President Bush, the federal government worked with manufacturers to accelerate vaccine development, stockpiled crucial antivirals like Tamiflu, war-gamed pandemic scenarios with senior officials, and increased the Centers for Disease Control and Prevention's (CDC) sample identification capabilities. These activities are bearing fruit today. The Department of Health and Human Services (HHS) has already deployed 12.5 million courses of antivirals -- out of a total of 50 million -- to states and local agencies. In addition, CDC's new capacities have allowed Mexican officials to send flu samples to CDC for quick identification, a capability that did not exist a few years ago. Collaboration between the government and the private sector on vaccines -- which Mr. Bush and his HHS team actively encouraged -- could potentially allow manufacturers to shepherd a vaccine to market within four months of identifying the strain and getting the go-ahead from CDC or the World Health Organization. But new tools aside, top health officials must answer difficult questions about response efforts. One is when and where to deploy antivirals. The Bush administration considered a "forest fire" approach to pandemic outbreaks abroad. This strategy calls for sharing some of our precious supply of antivirals with a foreign country in order to stop a small flame from becoming a forest fire. The risk is that we have only a limited number of courses, and the use of antivirals increases the odds that the flu strain in question will become resistant to that antiviral. With 37.5 million courses remaining in the federal stockpile, the administration needs to think very carefully about how to use them. Another issue: Under the Public Readiness and Emergency Preparedness (PREP) Act of 2006, the government has the authority to issue "Prep Act Declarations" granting liability protection to manufacturers whose products were used in public-health emergencies. This helps encourage manufacturers to develop countermeasures. The government issued a series of such declarations in 2007 and 2008. They protected the development and use of influenza vaccines and pandemic antivirals, as well as anthrax, smallpox and botulism products. The Obama administration should consider granting more of them -- if appropriate -- in the weeks ahead. A third policy question has to do with how to stop the spread of the disease both across borders and within countries. The administration has so far initiated "passive surveillance": Border guards are assessing if people entering the U.S. seem sick, but aren't actively stopping anyone. If things get worse, they may have to intensify border security. The Bush administration examined the question of closing the borders in certain circumstances but determined that it would probably be ineffective. Worse, it could lead other nations to retaliate by closing their own borders, which could hurt Americans traveling abroad. Another strategy, already in use to some degree in Mexico, is social distancing -- asking citizens to refrain from large social gatherings. During the 1918 influenza pandemic, St. Louis embraced such measures while Philadelphia eschewed them, and Philadelphia suffered a much higher death rate as a result. We are probably not yet at the point where such drastic measures are necessary, but senior officials had better start thinking about how they would address these questions. Most importantly, the federal government must figure out how to reassure a nervous public. It doesn't help that none of the 20 top officials at HHS has been confirmed. Some of them, like FDA commissioner-designate Dr. Margaret Hamburg, are experts in biopreparedness and could help reassure Americans. Alas, she and her potential future colleagues, including the new secretary of HHS, are still in limbo. They need to be in place and on the job. Mr. Troy, deputy secretary of Health and Human Services from 2007 to 2009, is a visiting senior fellow at the Hudson Institute. -
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April 29, 2009
Peter Pitts
From today's edition of the New York Times:
Lowering Drug Prices To the Editor: Pegging drug prices to health outcomes is a smart way to lower health care costs (“Drug Deals Tie Prices to How Well Patients Do,” Business Day, April 23). It’s also a patient-centric way of determining which drugs are worth the money. In Britain, New Zealand and elsewhere, government officials determine which drugs are worth the cost. These officials are under constant pressure to arrive at conclusions that lead to lower government spending, so patients are routinely denied access to expensive, cutting-edge medicine. Tying drug prices to patient performance is a model worth expanding. Tying drug prices to the whims of budget analysts heartlessly endangers lives. Peter Pitts New York, April 23, 2009 The writer is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration. -
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April 28, 2009
Dr. Robert Goldberg
For all the talk about slowing down the use of marginally effective techologies to "bend the curve" on rising health care costs I am surprised (not really) that advocates of comparative effectiveness have not brought up the near mothballing of both Relenza and Tamiflu back in 1999 after NICE nixed both as no better than placebo in reducing death in high risk populations. That year sadly the UK had an outbreak of flu, Relenza and Tamiflu were in short supply and thousands were sent to hospitals where there was no room. Hundreds died, waiting in freezer trucks because morgues were filled. Meanwhile Relenza went on life support and Tamiflu did come back to fight another day, but barely...
Today of course both drugs are the last line of defense against every possible pandemic, from avian flu to today's swine flu outbreak. Those who think economists can predict with certainty what will work and will be effective for all and for all times now and in the future should remember that human lives are in the balance and, as one NIH scientist has said with regard to developing a vaccine conjugant for swine flu, "this is biology, not mathematics." Read more here "GSK sued for 'abandoning' Relenza Friday , May 14, 2004 Biota, the Australian biotech company that discovered Relenza, is taking GlaxoSmithKline to court, alleging that it failed to properly launch and support the influenza treatment. After the breakdown of two years of talks between the companies, Biota is seeking an unspecified amount in damages for lost royalty revenues to date as well as future losses for the rest of Relenza's patent life. John Grant, chairman of Biota, said: "Litigation was the only reasonable option left to us to retrieve the substantial value we believe exists in Relenza." GSK licensed the product from Biota in 1990 and after its launch, captured 50% of the then emerging market for neuraminidase inhibitor (NAI) flu drugs in 1999/2000. But Biota said product sales went into free fall the following year after GSK cut virtually all its promotional efforts for the drug. Four years later, Relenza held just 3% of the NAI global market, which in 2003 was worth an estimated $330 million. In the UK, Relenza suffered the effects of a government-backed campaign promoting free flu immunisations for at risk groups and restrictive rulings from NICE. In its first ever appraisal in 1999, NICE controversially ruled that Relenza was neither cost nor clinical effective, although it did subsequently recommend use of the drug for at risk groups. A further appraisal in 2002 gave a highly restricted recommendation for both Relenza and its main rival, Roche's Tamiflu. GSK chose not to challenge that guidance, but Roche went on to win an appeal, gaining a new recommendation relating to flu prevention. But NICE stressed that vaccination remained the most cost-effective defence against flu. Last year Tamiflu increased its global sales by 184% to CHF431 million after a severe influenza outbreak in Japan and an early start to the US flu season. Biota's agreement with GSK entitles it to a 7% royalty on GSK sales of Relenza, which last year brought it less than $1 million in revenue. If the drug had achieved Tamiflu's market penetration, Biota says its royalty revenue from the drug would have been $35 million. Chief executive of Biota and former head of Pharmacia Australia Peter Molloy said: "Relenza was a breakthrough influenza drug that had great potential, but it was effectively abandoned at birth." -
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April 27, 2009
Dr. Robert Goldberg
CMPI Senior Fellow Marc Siegel puts the Swine Flu fear in health perspective....
Read Marc Siegel's piece here
I am glad that this outbreak is a swine rather than a bird flu, not because pig viruses are intrinsically safer than bird viruses, but because the greater lesson to guide us here comes from the 1976 pig hysteria, rather than from the 1918 bird flu plague." Anton van Rensburg
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April 27, 2009
Peter Pitts
Steve Usdin of BioCentury writes:
“Two recent incidents, one in which a prominent scientist was excluded from an FDA advisory committee because of statements he had made about a product, and another in which a patient representative voted to recommend against approval of a product that she thought had contributed to her son’s death, have led the agency to say it will reassess the way it screens for and responds to intellectual bias among panel members.” The issue isn’t financial conflict of interest, but rather intellectual bias. Is “intellectual bias” the same thing as a “Conflict of Interest?” And if it’s different, is it more or less or equally inappropriate? Here’s what Sid Wolfe has to say, “ “If one has views for or against something based on the data, that is called an intellectual process of trying to grapple with the issue, not bias.” BioCentury writes, “The issue isn’t a new one for FDA. The agency’s Advisory Committee Policy and Guidance Handbook, released internally in 1994 and still in use, has a two-page section on intellectual bias. The passage notes that “it is important that the FDA minimize the possibility of a member participating in discussions on issues where the member cannot be assured of participating objectively. FDA recently determined that Wolfe’s longstanding calls for a ban on the generic painkiller propoxyphene constituted intellectual bias. Wolfe was not permitted to participate as a member of the advisory committee in February when it met to consider the safety of propoxyphene.” The complete BioCentury article, “FDA Reviewing Intellectual Bias,” can be found here. I don’t believe that intellectual bias is a problem unless it rises to the level of conflict of interest. There is no such thing as a non-intellectually biased expert. If you are expert enough to be on a committee, you have strong opinions that others respect. There is a difference between bias and conflict of interest. I think the definition of conflict of interest needs to be somewhat expanded beyond a very narrow focus on dollars and cents. For example, “conflict of interest” can certainly mean having a child who is taking the product under discussion, whether that child had a positive or negative relationship with the product. That’s not a wild stretch of the imagination. Here’s a possible solution – prior to the agency’s final sign off, a designated senior FDA official should hold a final “job interview” (via phone or in person) with all potential advisory committee members. During my tenure at the agency I was the senior official in charge of advisory committees. There were no interviews as part of the process then -- and interviews aren’t part of the process today. I saw a plethora of multi-page resumes and written remarks and recommendations from various people from the appropriate center divisions. A decidedly two-dimensional proposition. It’s time for a third dimension. More work? Yes. More difficult? Sure. Worth the effort? Certainly. Saying anything else would be, well – intellectually biased. Cambridgian
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April 24, 2009
Peter Pitts
From today's edition of the Phillipine Daily Mirror:
Let's Reform Healthcare Without Growing the Government The nation's preeminent business organization recently released a study showing that the high costs of the American healthcare system puts American businesses at a significant disadvantage. The Business Roundtable, which represents some of the country's biggest corporations, found that for every $100 the U.S. spends on healthcare, our main competitor countries -- the United Kingdom, Canada, Japan, France, and German -- only spend about 63 cents. -
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April 23, 2009
Dr. Robert Goldberg
Not us in the US.. Or not by much.
Click Here to View Annual Canadian Expeditures The Canadians spend an average of $1932 dollars out of pocket. We spend about $2600. Most of the burden in Canada falls on the poor and seniors in the form of out of pocket costs for meds. Click Here to View Annual U.S. Expenditures Moreover, according the Peterson Institute for International Economics, our out of pocket costs have been dropping... despite all the propaganda flowing these days ... Household out-of-pocket healthcare expenditures, percent of total, 2006
Click Here to View the Full Story "Empirically, the share of total healthcare expenses that Americans pay out-of-pocket is lower than in the vast majority of European and other OECD countries for which recent comparable data are available. Americans are therefore generally more likely to ask someone else to pay for their health care than people in other OECD countries. In reality America’s healthcare system is already more “socialized” than in most European and other developed countries. Certainly, it is the case that Americans pay a higher absolute dollar amount in out-of-pocket expenses than almost anywhere else in the OECD (only Switzerland is higher). Yet that is solely because health care in America is so much more expensive than anywhere else and demonstratively not due to Americans being relatively more exposed to the “true costs of healthcare” than people elsewhere, let alone in countries practicing so-called “socialized medicine.” The simple fact remains that Americans are relatively less exposed to market forces and “the price mechanism” in health care than most people elsewhere, which is certain to be one more reason why Americans end up having to pay so much more for their healthcare." -
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April 23, 2009
Peter Pitts
You've certainly heard, "location, location, location." If you follow Microsoft you've heard, "developers, developers, developers." And now, if you're a believer in patient-centric reimbursement policies, there's a new triad, "outcomes, outcomes, outcomes."
It's about time. The story in today’s New York Times is headlined, “Drug Deals Tie Prices to How Well Patients Do,” but it could just as easily have been called, “Payers and Phama Focus on Patient-Centric Care.” The article, by the always excellent Andrew Pollack, begins thus: “Pressed by insurance companies, some drug makers are beginning to adjust what they charge for their drugs, based on how well the medicines improve patients’ health.” Outcomes baby! Pollack writes: “In a deal expected to be announced Thursday, Merck has agreed to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar. And last week, the two companies that jointly sell the osteoporosis drug Actonel agreed to reimburse the insurer Health Alliance for the costs of treating fractures suffered by patients taking that medicine.” Put up or shut up? That’s about the size of it. But it cuts both ways. “We’re standing behind our product,” said Dan Hecht, general manager of the North American pharmaceutical business of Procter & Gamble, which sells Actonel with Sanofi-Aventis. “We’re willing to put our money where our mouth is.” This outcomes-based strategy was first tried in Great Britain for the Johnson & Johnson drug Velcade and most recently for the Pfizer drug Sutent. J&J won coverage in 2007 after agreeing to pay back the government for people who didn’t benefit. Patients get the first four doses of the 762.38 pound drug, and then are tested to see if they’ve responded to the treatment. Those who improved continue with the drug. Johnson & Johnson provides a rebate of about 3,000 pounds for those who didn’t respond. For Sutent, the U.K.’s National Health Service (via NICE) decided the medicine extended the lives of patients enough to justify its cost, as long as the first course of treatment was free. According to Sir Michael Rawlins, Chairman of NICE, “We’re meeting them partway.” It's a creative approach based on outcomes -- a giant step towards recognizing the importance of personalized medicine the folly of basing reimbursement decisions on large-scale general population studies. And such strategies are also being designed to improve compliance. Pollack continues: “Some discounts will be granted if more people diligently take the drugs as prescribed. This helps both Cigna, because people who take their pills are likely to have fewer complications from the disease, and Merck, because it sells more pills. The assumption is that Cigna will push for patient-compliance programs that urge people to take their medicine at the right times and in the proper doses.” Imagine that, an access/reimbursement program that actually helps advance the four rights of 21st century personalized medicine – the right medicine for the right patient in the right dose at the right time. Sure beats a myopic, QALY-based view that puts cost ahead of care. Pollack quotes Eric Elliott, the president of Cigna Pharmacy Management: “We wanted a contract that drives performance,” he said. “Getting this one out will provide more momentum.” Focusing on outcomes not only means that Pharma will have to put their money where their mouth is – but that payers will have to put patients first. Now that’s healthcare reform. The complete New York Times story can be found here. -
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April 22, 2009
Peter Pitts
The FDA's Critical Path program must be seeded with more than bird feed. Here's why:
A team of FDA scientists and colleagues from the National Institute of Allergies and Infectious Diseases the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam; and Switzerland's Institute for Research in Biomedicine say their study of the avian influenza virus might lead to new tests that can detect such infections. The FDA said in-depth analyses of blood from patients recovering from the H5N1 virus also provided important insights into how to combat the potentially lethal virus and helps define what part of the virus is seen by the immune system. As one result of the research, the FDA scientists and their collaborators said a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus. The study appears online in the journal PLoS Medicine. Now imagine what the FDA could achieve if only Congress would release the designated funding for the Reagan/Udall Foundation. Collaboration is the key -- and the Critical Path has never been more critical. -
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April 21, 2009
Peter Pitts
Posting off-label trials on clinicaltrials.gov is a nefarious marketing technique? Give me a break.
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April 21, 2009
Peter Pitts
Regulatory Rapporteur is the name of a journal (www.topra.org) as well as as an apt moniker for Center for Medicine in the Public Interest Visiting Fellow Dr. Rick Turner.
Apt because of his excellent new article, "Drug Safety, medication, safety, patient safety: An overview of recent FDA guidences and initiatives." Rick's article can he found here. His abstract sets the stage: "Drug development and pharmacotherapy are components ofintegrated pharmaceutical medicine. The term ‘drug safety’ canbe used when evaluating adverse events during clinical trials, andwhen evaluating adverse drug reactions to a correctly prescribed, dispensed and administered drug. The term ‘medication safety’ refers to the evaluation of medication errors that occur at the prescribing, dispensing and/or administration level; endeavours to educate clinicians and patients about the correct use of a particular drug; and the design and implementation of safety systems and educational programmes to minimise these errors. Drug safety and medication safety are subsets of patient safety.Recent guidance documents and initiatives at the US FDA indicate the agency’s awareness of the paramount importance of safety considerations throughout drug development and pharmacotherapy, its commitment to expand and enhance its governance role in lifecycle drug development, and its commitment to play an infl uential role in the safe use of medicines." Turner's discussion of REMS, safe use, FDAAA, the Sentinel initiative, and other important items makes this article a must read. They don't call him "Page" Turner for nothing. -
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April 21, 2009
Dr. Robert Goldberg
Yom HaShoa fell on Hitler's birthday. Two groups of people were mindful of this dark coincidence. All Israelis -- or at least everyone I talked to -- knew about the overlap. They thought it was both poetic justice and divine intervention. Hitler didn't just want to destroy the Jewish people, he wanted the world to remember us. He envisioned creating a museum to house our corpses and conquered religious treasures -- torahs, talmuds, menorahs, tallit (prayer shawls), etc. to make eternal mockery of a people who believed in a G-d and way of life in which the absolute worth of each individual was the eternal foundation of society, behavior and technological progress. And of course the opposite has happened. Hitler is now a re-run on the History Channel and the Jewish people thrive and remember and are a reminder of both the mindless hatred of our enemies as well as our determination to fight and thrive as a nation.
The other group of people were of course not the clueless in the mainstream media. They were the audience the President of Iran played to by speaking -- on Hitler's birthday at a UN sponsored conference on racism rigged to engender more hate and promote the destruction of the Jewish state. As Ahmadinejad spoke European delegates to this conference on racism walked out in protest. Yet many of their own countries were party to cancelling Holocaust Remembrance ceremonies in various cities to "protest" Israel's military operation in Gaza in response to both rocket attacks and it's continuing project of establishing medium and long range missle capacity against major cities in Israel, courtesy of Iran. The irony of siding with those who eliminate the Jewish state as a form of protest was lost on these nation states. Similarly, the willingness to abet militant Islam in meaningless international conferences and expect to be congratulated for walking out on the speech of a monster...well now that I think about it, that's something the students at Columbia University didn't do! Once again history and the future of the Jewish people appear to be on a collision course. Throughout the world lip service is paid to our "right to exist", as if this is some sort of special gift from the family of nations and not something Jews -- mostly Israelis in the past 60 years -- have had to defend with their lives almost yearly. The promise of "Never Again" is uttered but in Europe and in the the halls of Congress and the mainstream media, attacks on the Jewish lobby are now part of the conversation. Modern day blood libel (the Gaza operation) is now the grist for playwrights who explore the Jewish soul and conclude it is dark, violent and racist to the core. England has become a cesspool of anti-Semitism and many in the American left are following suit. Sometimes I fear the world is slouching from indifference back to eon-old habits. Yet I believe Israel will prevail and the Jewish people will thrive precisely because of day's such as this one. In Israel at 10 am sirens wailed, traffic stopped, people stood still. For a minute the entire nation as one remembered, not just as a collective reminder of what preceded the establishment of Israel, but to show that one nation carved out of national tragedy will eternally bear witness to both the evil that nearly consumed the world and to our capacity not only rouse the conscience of others but to defend our existence the next time such evil rises again. We pause in silence. Not just to remember, but to underscore our willingness to set aside "normal" life and do what is required to survive, thrive and contribute to the world. It is 10:01 am. Life in Israel goes on. Am Yisroel Chai. -
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April 20, 2009
Peter Pitts
The issue at hand is opiods –but there’s a larger issue – how can the FDA, industry, physicians, pharmacists and patients work together to enhance the safe use of medicines.
The theory is that the way to make drugs “safer” is to ensure they are used appropriately. And communications is the weak link in the chain. Hence REMS as a tool for safe use. Seems to make sense. Presented for your consideration -- questions posed by the FDA in advance of a two-day public meeting set for May 27-28 on whether class-wide opioid REMS should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements. According to a report in the Pink Sheet, “Since FDA's announcement that it intended to seek the class-wide REMS in February, pharmaceutical companies have been charting new territory as they try to work together to develop a REMS framework for the whole class.” Working together to advance safe use. Good idea. The Pink Sheet continues, “The evolution of the opioid class-wide REMS will set an important precedent for trying to get competitors to work together on post-marketing programs in the future.” In short, competitors must also be allies in pursuit of the public health. And that means both innovator and generic companies. Not easy. But important advances rarely are. -
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April 17, 2009
Peter Pitts
The President has recently reaffirmed his conviction that "we must have quality, affordable health care for every American.” This is an important goal. In the health care debate, though, misconceptions abound — and this hurts reform efforts. As lawmakers move forward, they must be aware of the facts. And they must be clear on the precise causes of Prevention must be our first line of defense. Our health care system often works miracles when people become very ill, but it needs to do a better job at keeping people healthy before disease attacks. Although proper diet and nutrition are misunderstood and undervalued, better health care habits will not prevent the diseases that all Americans (and Baby Boomers in particular) will develop as we age. There are effective treatments, including medicines, which stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives rather than undergoing surgery, emergency care, hospitalizations, disabilities, and nursing home care. We cannot afford, in terms of either dollars or lives, to continue playing the health care "blame game," tending to focus on health care prices - for hospitals, insurance, drugs, and doctors. Disease is the enemy and the cost of disease is staggering. Rather than looking for a villain, it's time to start asking the hard questions and finding the right answers - focusing on how to reduce the price of a diabetic amputation is the wrong approach. We need to focus on prevention because that's the best way to save money and improve lives. Now is the time to do this, so that we can invest in and afford better treatments for other conditions such as cancer and Parkinson's disease, which are so desperately needed and that hold so much promise. All Americans deserve access to quality health care, but how can Americans get broader access to health care without diluting the quality of health care and compromising the future of health care? If miracles have become expectations - "What's a miracle worth?" For the rest of the story, see here. -
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April 16, 2009
Dr. Robert Goldberg
Comparative effectiveness research might lead to people being denied life saving care but at least they would get to choose the music they die to...free of charge I hope.... Hallelujah or Highway to Hell? Songs to die for AFP/File – US entertainer Frank Sinatra sings in Washington, 1992. Sinatra's "My Way" is the most … LONDON (AFP) – Frank Sinatra's "My Way" is the most popular song played at funeral services, but other more arresting death-bed choices were revealed in a poll published in Britain Thursday. Australian rockers AC/DC's "Highway to Hell" has stormed into the funereal charts along with Queen's "Another One Bites The Dust," while Leonard Cohen's "Hallelujah" has a new lease of life after its recent success on a talent show. More traditionally, hymns including "The Lord Is My Shepherd" and "All Things Bright And Beautiful" are among music chosen by people to accompany their final journey. For classical music fans, Schubert's "Ave Maria," Puccini's "Nessun Dorma" and Bach's "Air On A G String" are among the most chosen pieces to comfort their loved ones as they pay final farewells. Television and radio music also features on the burial playlist: theme tunes from popular programmes like "Top Gear", "The Benny Hill Show" and even the Radio Four Shipping Forecast music, which many fall asleep to at night. Ben Hansen
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April 16, 2009
Mario Coluccio
A new study recently released confirms our worst fears: Many physicians in the United States regret having gone into the medical profession. The study, conducted by HCD Research, reveals that 30% of physicians in the United States would choose a different profession today if they had the chance to start over. The two main reasons cited by doctors for their dissatisfaction are negotiated rates and medical malpractice lawsuits. This study’s revelation is all the more troubling given that Congress is considering the establishment of a new public health plan which would impose more “negotiated” rates on physicians. The Wall Street Journal recently reported that “A growing number of doctors have stopped accepting or limited the number of new patients they see on Medicaid, a state-administered insurance program for the poor, because governments have been freezing or reducing payments to caregivers. As a result, the Medicaid reimbursements often don’t cover physicians’ costs.” Why are policymakers flirting with legislation that will only serve to exacerbate the growing frustration of physicians? Susan Dorfman
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April 16, 2009
Mario Coluccio
With health care reform front and center, opposing sides are easily reduced to citing stats and figures which purportedly prove their respective arguments correct. Often not discussed (at least not in the way it should be) in the exchange is the level of care afforded those patients who face serious illness in the various systems being debated. After all, it is one thing to be “covered.” It is another thing for the government (in a universal healthcare system) to pull out all stops in an attempt to save your life. One such person who puts a human face on the grievous downsides of government-controlled health care is Virginia Postrel. Virginia Postrel, a breast cancer patient, was saved by a drug called Herceptin. She recently detailed her battle against breast cancer and her ongoing fight to ensure that other cancer patients are not denied life-saving drugs because government bureaucracies deem said drugs not “cost-effective.” Her story is emotionally potent and should be required reading for those US policymakers hellbent on taking this country down the road to government-run healthcare. Here are a few excerpts from Postrel’s piece worth repeating. On the U.S. health care system as a driver for biomedical innovation and medical progress: The American health-care system may be a crazy mess, but it is the prime mover in the global ecology of medical treatment, creating the world’s biggest market for new drugs and devices. Even as we argue about whether or how our health-care system should change, most Americans take for granted our access to the best available cancer treatments—including the one that arguably saved my life. On Herceptin: Starting in the late 1990s, oncologists had used Herceptin to extend the lives of patients whose HER2-positive cancers were advanced and metastatic, buying them months, and in some cases years, of life. Then, in May 2005, reports of clinical trials on patients with early-stage HER2-positive breast cancer electrified the American Society of Clinical Oncology’s annual meeting. Herceptin halved the chances of cancer recurrence: from one in six to one in 12 after two years. No one knew what would happen after five or 10 years, but the preliminary results were, to quote a New England Journal of Medicine editorial, “stunning.” For breast cancer that hasn’t spread elsewhere in the body, Herceptin offers the possibility of a cure. It enhances chemotherapy, encourages the immune system to attack cancer cells, and hinders those cells from reproducing. A year of the drug, with one dose every three weeks (or, for some patients, along with weekly chemotherapy), is now the international standard of care for patients with cancers like mine. So, along with chemotherapy, another round of surgery, and seven and a half weeks of daily radiation, that’s what I got. The Herceptin treatments cost my insurer about $60,000. A year later, I have no evidence of disease and, though it’s still early, I have hope of staying that way indefinitely. On New Zealand’s “cost-effective” approach to treating patients compared to the United States: Not everyone in similarly rich countries is so lucky—something to remember the next time you hear a call to “tame runaway medical spending.” Consider New Zealand. There, a government agency called Pharmac evaluates the efficacy of new drugs, decides which drugs are cost-effective, and negotiates the prices to be paid by the national health-care system. These functions are separate in most countries, but thanks to this integrated approach, Pharmac has indeed tamed the national drug budget. New Zealand spent $303 per capita on drugs in 2006, compared with $843 in the United States. Unfortunately for patients, Pharmac gets those impressive results by saying no to new treatments. New Zealand “is a good tourist destination, but options for cancer treatment are not so attractive there right now,” Richard Isaacs, an oncologist in Palmerston North, on New Zealand’s North Island, told me in October. A more centralized U.S. health-care system might reap some one-time administrative savings, but over the long term, cutting costs requires the kinds of controls that make Americans hate managed care. You have to deny patients some of the things they want, including cancer drugs that are promising but expensive. Policy wonks dream of objective technocrats (perhaps at the “independent institute to guide reviews and research on comparative effectiveness” proposed by Barack Obama) who will rationally “scrutinize new treatments for effectiveness,” as The New Republic’s Jonathan Cohn puts it. But neither science nor liberal democracy works quite so neatly. To read this piece in its entirety, click here. Yuri
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