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
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?
This is an abomination, especially if a super-majority is needed to kill it.
Article published Jun 28, 2009
Doctor shortage proves painful to state
By BRENT CURTIS Staff Writer
Much of the state is short on primary care providers at a time when the nation as a whole is searching the same pool of doctors.
Since the start of the year, Rutland County, for example, has lost three primary care doctors and three more are over age 60 and planning to retire within the next few years, said Rutland Regional Medical Center President Thomas Huebner.
"We have the biggest shortage of primary care doctors in the state," Huebner said, pointing to a 2008 state Department of Health report that indicated that all but a tiny portion of the county faced a "severe need" for primary care physicians.
And that study was conducted before the departure of three primary care doctors earlier this year.
The loss of those doctors is more than just an inconvenience for their patients. With the demand for primary care in Rutland County exceeding the supply – which Huebner said is short by about four doctors – patients are forced to wait longer to see doctors who are overburdened. Also, many doctors in the region aren't accepting new Medicare or Medicaid patients – most physicians can only accept so many state-insured patients due to low government reimbursement rates – which compels many patients to put off doctor visits until their needs are acute and they end up in the hospital.
It's a fallback practice for those who can't find primary care doctors that Huebner and other health care professionals say ends up costing hospitals, insurance companies and ultimately those paying for insurance more.
And the primary care problem hardly is unique to Rutland or to Vermont for that matter.
Elsewhere in the state and nation, primary care physicians are in short supply.
Dr. Ted Epperly, president of the American Academy of Family physicians, said the United States is about 15,000 primary care doctors short of demand — a 30 percent shortfall across the board for all 50 states.
If current trends persist, the AAFP predicts the deficit will grow to 40,000 over the next 10 years.
That estimate is no surprise given that only 17 percent of U.S. medical school graduates in 2008 expressed a preference for family medicine. The AAFP said the small percentage of primary care-minded graduates represented an "all-time low" among emerging students.
Even in Vermont, where the University of Vermont prides itself on ranking in the top 5 percent of all medical schools for primary care, access to family medicine is spotty.
In addition to Rutland County, large swaths of the Northeast Kingdom along with large portions of Grand Isle, Franklin, Lamoille, Addison, Orange, Washington and Windham counties were labeled "severe need" areas by the Department of Health. Many other areas of the state were listed as "limited need" areas.
In fact, the only sizeable areas with adequate supplies of primary care, according to the most recent state study that compares full-time equivalent hours with regional populations, were portions of Chittenden, northernmost Orleans, southern Addison, much of Windsor, central Windham and most of Bennington counties.
The reasons for the doctor shortage, which has been gradually worsening over the years, are well documented. Much of the problem boils down to money. Medical students who opt to specialize rather than enter primary care practices stand to make significantly more because specific procedures earn higher reimbursements than generalized care and diagnoses. For medical students leaving school with debt loads often topping $150,000, the decision to enter primary care practice often means a degree of financial hardship, according to survey-based research conducted in Vermont and nationwide.
Those same surveys show that primary care physicians tend to work longer hours than specialized doctors and must juggle larger caseloads with the reams of paperwork that accompany most procedures in modern medicine.
In Rutland, Huebner said those symptoms are particularly acute due to high ratios of Medicaid and Medicare patients in the community. Reimbursements from the two government programs are well below the cost of medical procedures.
Vermont can be a tough place to recruit new doctors who can often find higher wages in other states, according to the Vermont Medical Society.
"What Vermont has going for it is quality of life," said Paul Harrington, executive vice president of VMS. "Nothing trumps a desire to be here because there are other places where doctors do earn more."
On top of that, Harrington said Vermont has a higher ratio of Medicaid patients and an ever increasing number of Medicare patients due to a graying population.
The pay scale puts Vermont at a disadvantage when it comes to recruiting new doctors – and it makes keeping them here a challenge, as well.
Since the primary care shortage is a national problem, other states constantly are trying to lure doctors away from Vermont.
To keep physicians here, hospitals around the state utilize their own recruiters who not only try to bring doctors to their facilities but work toward a balance of doctors in private practice in the surrounding communities as well.
Hospitals have an interest in the medical community beyond their own walls because a shortage of primary care doctors means more patients arriving in the emergency room suffering from ailments that a family physician could have detected and dealt with at a less acute and less expensive stage.
"We're all in this together," said Donna Izor, vice president of physician services at Central Vermont Medical Center.
Izor, and other recruiters around the state, offer incentives such as electronic medical records, startup loans and hospitallist services – hospital employed doctors who oversee a primary care physician's patients during hospital stays – to ease the financial, paperwork and time burden that family physicians shoulder.
But all acknowledge that the real answer to the problem lies at the state and federal level, where Medicaid and Medicare reimbursement levels are set – and all too often are cut.
During the last legislative session, budget realities prompted legislators to cut Medicaid reimbursements by 2 percent.
In the Legislature's defense, Rep. Steve Maier, D-Middlebury, said legislators exempted a number of procedures common to primary care physicians from those cuts and he said the Legislature increased Medicaid reimbursements for some primary care procedures.
"We know there's a shortage and we know that quality primary care saves money for the system in the long term," said Maier, who is chairman of the House Health Care Committee.
The Vermont medical community is also looking at changing the way that primary care is delivered. Through a blueprint model originally developed to handle chronic care for patients, three pilot programs are underway in Burlington, Bennington and St. Albans that will provide a small supplemental sum for each primary care provider in the pilot. More importantly, the blueprint pilot establishes a team approach that would surround primary care doctors with physician assistants and specialists, who the pilot's drafters hope will assist family physicians and relieve some of their time and caseload burden.
Huebner said he is seeking to make Rutland the fourth pilot site for the blueprint.
In the meantime, the RRMC president said he's looking ahead to the opening of a federally qualified health care center at 69 Allen St. later this summer.
The center, which will serve as a satellite for the main FQHC center in Castleton, is starting small with just a single doctor, but Huebner said he has applied for funding to expand the practice by building a center on land owned by the hospital.
There are eight other FQHC centers in the state – the one in Springfield is the newest – and 34 satellite offices. The centers' greatest asset is something of a commentary on the underlying problem confronting other primary care doctors – they are paid a much higher reimbursement for Medicaid and Medicare patients.
The FQHC facilities operating in the state cover a majority of the state's 14 counties.
But independent U.S. Sen. Bernard Sanders, who has advocated for additional centers for years, said he won't be satisfied until two more centers are added in Addison and Bennington counties.
Sanders said this week that he has had recent success expanding the FQHC program, which will create 126 new health centers nationwide this year.
"We have 60 million people out there with no doctor of their own," he said. "What we need to do and work on is making sure that every person in the nation has access to a doctor."
Harvard Teaching Hospitals Cap Outside Pay
The owner of two research hospitals affiliated with the Harvard Medical School has imposed restrictions on outside pay for two dozen senior officials who also sit on the boards of pharmaceutical or biotechnology companies. The limits come in the wake of growing criticism of the ties between industry and academia.
Medical experts say they believe the conflict-of-interest rules at the institution, Partners HealthCare, go further than those of any other academic medical center in restricting outside pay from drug companies. The rules, which became effective on Friday, impose limits specifically on outside directors who guide some of the nation’s biggest companies.
http://www.nytimes.com/2010/01/03/health/research/03hospital.html?pagewanted=printWill someone please explain to me what the downside of such ties are as long as all relationships are transparent and the research conducted is done so at arms length? Should academia receive no industry support of any kind?
However, it's okay for business professors who criticize pharma ties to academia to disgorge huge consulting fees from said corporations...
"Thomas Donaldson, a professor of business ethics at the Wharton School of the University of Pennsylvania, said: “It strikes me as a breath of fresh air in a room that’s getting progressively more stale. I hope this will set a standard for others — hospitals, medical schools.”
Professor Donaldson, who advises large companies on corporate governance, said dual roles in a hospital and at a drug maker were “dicey at best” because a director’s duty is to look out for the corporation’s financial interests.
The irony or hypocrisy is not even noted because, well, only pharma dough is evil. Meanwhile, I have obtained a photo of the new Partners RNAi antibodies facility... paid for from medical students actvitivy fees
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.
