Washington (AP) - New drugs cleared by the Food and Drug Administration last year kept pace with 2008, suggesting a much-touted push for drug safety has not slowed down approvals.
The FDA's new leaders did step up early warnings about potential drug safety issues and citations to companies that violate safety regulations.
Drug approvals inched higher to 26 first-of-a-kind prescription medicines last year, from 25 in 2008, according to figures from Washington Analysis, an investment research group. New drugs cleared in 2009 included Novartis' kidney cancer drug Afinitor and Bausch and Lomb's pink eye medicine Besivance.
The FDA hasn't yet tallied its year-end drug approvals but will have the number by Friday. As of Dec. 1 the agency reported 25 new drugs approved.
During 2009, the agency added 31 new or updated "black box" warning labels to drugs already on the market. That was down from 56 boxed warnings in the previous year, when the agency issued several broad warnings that resulted in boxed labels for entire groups of drugs.
The 2009 totals suggest a moderate approach to regulation from FDA, despite drug industry concerns that recently-appointed Obama administration officials would result in fewer drug approvals.
President Barack Obama tapped Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein last year to restore the agency's credibility, following a string of safety problems involving everything from blood thinners to peppers to peanut butter.
In August, Hamburg announced the agency would speed up and expand its issuance of warning letters to companies that don't follow FDA regulations.
"The agency must show industry and consumers that we are on the job," Hamburg said. "Companies must have a realistic expectation that if they are crossing the line, they will be caught."
Analysts say the take-charge attitude has energized the staff and empowered them to make decisions.
"Sharfstein and Hamburg bring confidence and certainty to an agency that was badly in need of it," said Ira Loss, an analyst with Washington Analysis who has covered the agency for three decades. "The rank-and-file staffers are now able to move with confidence that the agency has their back."
In the past year, the FDA also increased its use of so-called early communications, a sign the agency is acting more quickly to address safety concerns. Under the policy, the FDA issues warnings to the public when it first begins looking at potential side effects with a drug, even if no direct link has been established.
The agency issued five early communications last year, including reports of liver damage with GlaxoSmithKline PLC's over-the-counter weight loss pill alli and heart problems with Roche's asthma drug Xolair. Both issues are still under investigation. In 2008 the agency issued two early communications.
FDA also stepped up actions against bogus or dangerous consumer products.
Since last spring, FDA regulators moved to shut down makers of phony swine flu remedies, defective nasal sprays and dietary supplements that contain steroids.
Drug industry executives have criticized the FDA in recent years for approving fewer new drugs. Drug approvals peaked at 53 in 1996 and have bounced around in the twenties and teens in recent years. Many critics suggest the agency has become too cautious in response to the safety scandal surrounding Vioxx, the Merck painkiller which FDA approved in 1999 but then pulled from the market in 2004 due to heart risks.
FDA officials have countered that new drug submissions have been declining for a decade as companies struggle to come up with new medications. The FDA can't approve drugs that aren't submitted.
The agency says it has addressed staffing issues that slowed reviews in recent years, and is operating within its goal of taking 10 months to review regular drug applications and six months for priority applications.
Latest Drugwonks' Blog
What is the response?
Let Arnold Relman and David Rothman (he who receives his dollars from George Soros) render judgment:
Relman: “But it’s just not a good idea for a profession that says it wants to be independent and trusted, a reliable source of information to the profession and the public about drugs, to take money from the drug company under any conditions.”
Rothman: I will also confess I am surprised Pfizer is doing it,” he added, “and I don’t know how many more times they will give money with no strings attached.” (As opposed to the tight strings attached to everything Soros gives to his sock puppets?)
So doctors who take unrestricted money for any reason under conditions from any company are inherently corrupt?
Too bad the NY TImes continues to give these extremists a platform -- without ask them to disclose their funding sources... as if that mattered.
www.nytimes.com/2010/01/11/business/11drug.html
Harvard Pilgrim Health Care Inc. has won a major grant from the Food and Drug Administration to build a system to monitor the safety of drugs and medical devices after they have gone on the market.
Pilgrim will use a five-year, $72 million grant to coordinate the efforts of 28 health care organizations around the country as they design ways to make use of information they already gather, in electronic medical records or claims data, to provide early warning of potential harm.
“The goal is to be able to do active surveillance, to look for signals that might indicate there is a safety problem and then to be able to follow up to determine whether there is a problem or not,’’ said Dr. Richard Platt, who will lead the effort. He is chairman of population medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. “This is part of a major shift on FDA’s part from being reactive, waiting for physicians and patients to tell them about problems, rather than to be looking actively for problems.’’
"We do not support approaches, such as those suggested in the Senate's proposed Independent Payment Advisory Board, that rely too heavily on the Medicare program to achieve cost-containment objectives." So said AARP CEO Barry Rand in a letter sent to Senate Majority Leader Harry Reid and Speaker of the House Nancy Pelosi.
The provisions in the Senate bill task the 15-member board with reducing excess cost growth by recommending cuts in Part D premium subsidies paid by Medicare. Those recommendations mandate fast-track congressional action, required within two-and-a-half months unless the Senate has a three-fifths vote to repeal the board recommendations or any of the savings targets.
Rand continues, "Congress should not abdicate its role of determining benefits and cost-sharing for Medicare.”
Mr. Rand is right. One of the most frightening unintended consequences of such an advisory board is that they will make decisions based on cost rather than care. And it’s an inevitable consequence. Those who owe their jobs to the American voter must always be held ultimately responsible for government reimbursement decisions. And if you don't think this really makes a difference -- just ask the folks at NICE about Sutent.
Make patients' needs a higher priority
The Senate's vision for health care reform - the "Patient Protection and Affordable Care Act" - would create a "Patient-Centered Outcomes Research Institute." This institute would aim to compare the effectiveness of different treatments to "assist patients, clinicians, purchasers, and policy-makers in making informed health decisions." ("Purchasers" refers to public, private and employer-sponsored health insurance.)
As the founding editor of "The Patient - Patient-Centered Outcomes Research" - the first medical journal devoted exclusively to informing the health care system about patients' needs and wants - I have several reservations.
It is unclear how the institute will define, let alone meet, the often-competing interests of patients, clinicians, purchasers and policymakers. While clinicians, purchasers and policymakers have adequate means and resources for advancing their interests, it is questionable whether the patient's voice will be adequately represented in this process. Despite the many patient organizations representing specific diseases, only a few are active in research, and these may be tarnished through funding by pharmaceutical companies. Furthermore, unlike clinicians and purchasers who are bound together by their commercial and professional interests, representing the range of patient perspectives is difficult and expensive.
"Patient-Centered Outcomes Research Institute" sounds like a more politically palatable name for an "Institute for Comparative Effectiveness Research." Like other such agencies internationally, the bill gives the institute the power to determine the "appropriateness of medical treatments." International experience demonstrates that "appropriate" is defined as cost-effective or budget minimizing (although our senators have carefully avoided such terms). Also like its international counterparts, the institute would be placed at arm's reach from government, to ensure lawmakers have plausible deniability with regards to health care rationing.
Finally, similar institutes internationally have been criticized for promoting "one-size-fits-all" medicine by ignoring variations in needs and wants across patient populations. While the institute will consider "variations in patient subpopulations," it is unclear what characteristics will define such subpopulations.
A centralist and paternalistic approach is found throughout bill's description of the institute. Already a number of professional organizations have expressed concern that the institute would control the health care system by controlling the flow of information. Internationally, this occurs explicitly through limitations on the advertising of pharmaceuticals and implicitly by restricting funding of research. While the new institute will have a role in "the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments," a truly patient-centered approach would also focus on the patient's perspective.
There is little federally funded research focused on the patient's perspective. Knowing more about what patients think might have resulted in less of an uproar over the recent changes to breast cancer screening recommendations, for example.
It is unclear how the findings of the institute will we implemented. Similar institutes overseas cannot have their decisions challenged in court. In trying to be everything to everybody, the institute will need to make trade-offs that will most likely promote clinician-centered or payer-centered outcomes research - ignoring the disparate needs of patients.
House and Senate negotiators should create a separate institute for the scientific study of the patient's perspective, an "Institute of Patients' Needs and Wants," to conduct and fund real patient-centered outcomes research. Such an institute would not only provide necessary oversight, but more importantly, the input of the patient's perspective and participation in health care decisions, from start to finish.
John F. P. Bridges is an assistant professor in the Department of Health Policy and Research at the Johns Hopkins Bloomberg School of Public Health and a senior fellow at the Center for Medicine in the Public Interest.
The Lessons of Medicare Part D
By DAVID WESSEL
Four years ago, the U.S. government offered subsidized prescription-drug insurance to 43 million elderly and disabled, the biggest expansion of government-backed health care in decades. Today, the program is working better than many expected. Now academics are drawing lessons that are acutely relevant to heath-care legislation pending in Congress.
Medicare Part D did lead the elderly to use more drugs. (That's unsurprising, but pleases economists because it confirms their predictions that when government subsidizes something, people use more of it.) More important is the conclusion from Nobel laureate Daniel McFadden of the University of California at Berkeley: "Medicare Part D … has achieved its primary political goal of providing near-universal coverage in a viable private market." (Link for paper)
Some early lessons:
Markets do work, but...
In Medicare doctor and hospital insurance, the government generally chooses benefits and sets prices. In Part D, there is no government plan; the typical elderly person has a choice of 40 plans, all sponsored by private insurers whose offerings are supervised by the government. Few elderly pick really lousy plans; the government makes sure no really lousy plans are offered, an important lesson for the "exchanges" at which many Americans would shop for private health insurance under the pending bill. Jonathan Gruber and Jason Abaluck of the Massachusetts Institute of Technology, with data on 2.7 million Part D enrollees, find that 70% could have chosen a lower-cost plan, and the typical enrollee could have saved about 25%. (Link for paper.) Consumers focused too much on premiums, not enough on out-of-pocket spending. It's a reminder that elaborate cost-sharing formulas don't guide consumers well if they're too complicated for consumers to understand.
"Markets definitely work," says John Hsu, a physician-MBA at Harvard Medical School. "However, they don't always work according to original assumptions. It's very important to examine each step very carefully to look for unintended consequences."
Prices don't always do the predictable.
The early fear was that arming the elderly with subsidized drug insurance would increase demand and thus drug prices, especially since Congress barred the government from negotiating drug prices directly. That task was left to the private insurers.
Insurers had strong incentive to bargain hard. Mark Duggan of the University of Maryland and Fiona Scott Morton of the Yale School of Management conclude, "Moving consumers into Medicare Part D plans significantly reduced the per-dose price paid to manufacturers." (Link for paper.) Average price cut: 12%. Why? "An individual consumer typically does not have the knowledge of which drugs are acceptable [cheaper] therapeutic substitutes; the consumer's physician typically has poor knowledge of [drug] prices and any one consumer is too small...to negotiate with a pharmaceutical company."
That strengthens the case for harnessing private insurers to restrain health costs, but doesn't mean drug prices couldn't be lower still. The Medicaid program for the poor and the Veterans Administration get even lower drug prices. That matters particularly to the elderly poor who may pay more for drugs because they were switched to Medicare Part D from Medicaid.
One countervailing force: an uptick in drug-company ads aimed at elderly consumers. In unpublished work presented at the American Economic Association this week, Darius Lakdawalla of the University of Southern California compared direct-to-consumer ad spending on drugs with no Medicare use with ad spending on drugs typically used by Medicare patients. After Part D kicked in, spending on the latter rose 60% above spending on drugs with no Medicare users.
Programs never cost what the experts predict.
Economy-wide growth in drug spending slowed surprisingly sharply. "This sharp deceleration in growth rates was unexpected by us, CBO, and most industry experts," CMS chief actuary Richard Foster said in an email to Slate's Tim Noah. "It occurred largely as a result of effective efforts by health-insurance plans to induce people to use generic equivalents and a slowdown in the number of new "blockbuster" drugs coming into the market." Projections are always wrong, he notes, but still essential to wise policy making.
Health care is never simple, though. Higher drug spending pulled down hospitalization of the elderly for diseases treatable by medicine, such as diabetes. "It did make them healthier and keep them out of the hospital," Michael Chernew of Harvard Medical School said at an AEA presentation.
Of course, Congress is often happy to spend those savings and more. Douglas Holtz-Eakin, CBO chief when the drug bill passed, notes that Congress now is contemplating filling "the doughnut hole" -- out-of-pocket spending on drugs that wasn't covered by the original plan. "Every entitlement program gets richer over time," he says.
FDA Warns Public of Continued Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.
The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.
The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.
"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment.”
FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.
Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.
In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.
The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA’s concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.
Push for Drug Safety Did Not Slow FDA Drug Approvals Last Year
Wednesday, January 06, 2010
By Matthew Perrone, Associated Press
Personalized medicine means the “Four Rights” – the right medicine for the right patient, in the right dose at the right time. We’ve made some significant strides forward via (among other things) molecular diagnostics – but we’ve only scratched the surface.
Consider two recent studies on how we’re diagnosing and treating depression.
According to the Wall Street Journal, “More Americans are being prescribed multiple psychiatric medications for use at the same time, but most people diagnosed with recent depression don't get adequate treatment, according to two independent studies published Monday.”
Advancing the tools and techniques of personalized medicine is real healthcare reform. And there’s no better place to start than with the FDA’s Critical Path Program and its Reagan Udall Foundation.
To paraphrase – we have promises to keep. And miles to go before we sleep.
Drugs May Aid Only Severe Depression
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday.
The findings could help settle a longstanding debate about antidepressants.
NOW WATCH AS CAREY DUMPS ON MEDS IN A BACKHAND WAY..
While the study does not imply that the drugs are worthless for anyone with moderate to serious depression — many such people do seem to benefit — it does provide one likely explanation for the sharp disagreement among experts about the drugs’ overall effectiveness.
Taken together, previous studies have painted a confusing picture. On one hand, industry-supported trials have generally found that the drugs sharply reduce symptoms. On the other, many studies that were not initially published, or were buried, showed no significant benefits compared with placebos.
THE LAST GRAF IS NONSENSE. NO TRIALS -- INDUSTRY OR OTHERWISE HAVE EVER SHOWN THAT ANTIDEPRESSANTS SHARPLY REDUCE SYMPTOMS. THEY ARE HARD TO DESIGN AND ENDPOINTS HARD TO MEASURE. MANY ARE TO0 SMALL. WHICH IS WHY MANY ANTIDEPRESSANT STUDIES ARE NOT PUBLISHED. RATHER IT HAS BEEN THE CUMULATIVE CLINICAL EXPERIENCE THAT HAS DEMONSTRATED BENEFIT IN LARGE PART BECAUSE TESTING AGAINST PLACEBO DO NOT TAKE INTO ACCOUNT THAT 60 PERCENT OF ALL PEOPLE WHO START ON ONE ANTIDEPRESSANT SWITCH. THUS THE STAR-D TRIAL, A GOVERNMENT FUNDING STUDY THAT USE A CROSSOVER DESIGN MIMICING CLINICAL PRACTICE FOUND SIGNIFICANT BENEFITS THROUGH THE INDIVIDUALIZATION OF TREATMENT. WHEREAS...
The new report, appearing in The Journal of the American Medical Association, reviews data from previous trials on two types of drugs and finds that their effectiveness varies according to the severity of the depression being treated.
Previous analyses had found a similar pattern. But the new study is the first to analyze responses from hundreds of people being treated for more moderate symptoms, as are most people who seek care.
AGAIN, UNTRUE.. SEE THE STAR-D TRIAL
“I think the study could dampen enthusiasm for antidepressant medications a bit, and that may be a good thing,” said Dr. Erick H. Turner, a psychiatrist at Oregon Health and Science University. “People’s expectations for the drugs won’t be so high, and doctors won’t be surprised if they’re not curing every patient they see with medications.”
But Dr. Turner added, “The findings shouldn’t dampen expectations so much that people refuse to even try medication.”
A team of researchers, including psychologists who favor talk therapy and doctors who consult widely with drug makers, performed the new analysis, using government grants. The group evaluated six large drug trials, including 728 men and women, about half of them with severe depression and half with more moderate symptoms.
Three of the trials were of Paxil, from GlaxoSmithKline, a so-called S.S.R.I., and the other three were of imipramine, an older generic drug from the class known as tricyclics. The team, led by Jay C. Fournier and Robert J. DeRubeis of the University of Pennsylvania, found that compared with placebos, the drugs caused a much steeper reduction in symptoms of severe depression (cases scoring 25 or higher on a standard scale of severity, putting them in the top quarter of the sample). Patients with scores of less than 25 got little or no added benefit from the medications.
“We were able to give an overall estimate of effectiveness for the first time in this more moderate severity range, from 14 to 20 on the scale, in which there’s no question that doctors would likely consider prescribing medication,” Dr. DeRubeis said.
His co-authors included Steven D. Hollon and Dr. Richard C. Shelton of Vanderbilt University, Sona Dimidjian of the University of Colorado, Dr. Jan Fawcett of the University of New Mexico and Dr. Jay D. Amsterdam of Penn.
The effects of other popular S.S.R.I.’s like Lexapro and Prozac are not likely to be much different than those of Paxil, experts said.
Dr. DeRubeis and others said antidepressants’ inability to outperform placebos against moderate symptoms stemmed partly from the sustained attention that patients in drug trials received from top doctors — which itself can help relieve symptoms, drug or no drug. For some people, too, the drugs’ side effects may cancel any benefit.
HOW ABOUT THE USE OF GENETIC TESTS TO INDIVIDUALIZE AND OPTIMIZE DRUG SELECTION TO REDUCE SIDE EFFECTS?
THIS IS A POOR STUDY RECAST AS A SLAM AGAINST MEDICATIONS BY THE NYTIMES
FOR THOSE INTERESTED IN THE STAR-D RESULTS AND IMPORT.
Bloomberg reports that “Democrats will likely drop the idea of setting up a new government-run insurance program as they try to quickly resolve differences between House and Senate health-care bills, party members in both chambers said.”
Illinois Senator Dick Durbin, the No. 2 Senate Democrat said, “The Senate has pushed this to the limit of 60 votes. We have to be careful that whatever we change doesn’t jeopardize that 60-vote margin.”
“We’ll never have another chance like this in my political lifetime,” Durbin said. “This is it.”
Healthcare reform is too important to tie it to Senator Durbin’s political lifetime. The American public is not concerned about Senator Durbin’s political lifetime.
The goal, according to Bloomberg, is to have a bills signed by the State of the Union.
Shouldn’t the goal be to pass healthcare reform legislation that advances the public health in smart and progressive ways? Why the artificial deadline?
Should we accept legislation that compromises the public health?
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.
