Latest Drugwonks' Blog
Reps. John Dingell and Bart Stupak on Thursday questioned whether FDA officials knew about the potentially fraudulent information but approved Ranbaxy's products anyway.
Stupak said the Ranbaxy case "may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them."
The Rambaxy situation is very unsettling and certainly worthy of investigation. Casting such snide unfair aspersions on the hard working career staff of the FDA is not.Mr. Stupak -- apologize now!
Take a look at the response to the allegations that Ranbaxy was hiding data from the FDA about the safety and integrity of their products. Large company is accused of willingly conspiring to evade and avoid FDA scrutiny even as it submits the "right" data and who is hauled before Congress?
FDA, the same FDA that has been lambasted for being short of staff. It is now being all but accused of conspiring with Ranbaxy.
If importation becomes a free trade zone for counterfeiters, you will see more evasion as the opportunities for profit and piracy pile up.
Don't expect Congress to take the blame for poisoning our medicine supply.
Read more here
Ron Paul videocast
Not surprisingly, he has a lot to say -- but we tried to keep him focused on healthcare.
And we were almost successful. You be the judge.
It’s surprising how much ink is being spilled over the revised PhRMA code – considering it bans free pens.
Commission’s rigorous testing helps ensure interoperability of technology
As Congress takes up the subject of health information technology, it must take great care to enable accelerated progress rather than sending the process back to the starting line.
My vision of health information technology in the
Getting health information systems in various parts of the healthcare system to work together requires the adoption of common technical standards. I’ve often compared the problem to the building of railroads. Before the railroads of the East, West, North and South could be interoperable, they all had to agree on one standard track size. A similar process is required with health IT, except that the degree of difficulty is much harder than just agreeing on a track size.
There are more than 200 developers of electronic medical record systems in the
Until three years ago, there was no process for harmonizing and coordinating the standards they used. To remedy this problem, we formed the American Health Information Community (AHIC). It has succeeded, and as time passes we are seeing an accelerating stream of solid and widely accepted health IT standards emerge.
People who buy systems need to know they are making an investment that will connect them with the rest of the medical world. Today, they can buy with confidence.
The Certification Commission for Healthcare Information Technology gives systems a rigorous testing to demonstrate interoperability. Those systems that pass the test are given CCHIT certification. When doctors buy systems with that seal, they know that they are on a pathway to interoperability. This has given many doctors the confidence to buy who were waiting before.
We have seen more progress toward interoperability in the past three years than in the previous two decades. This is because government agencies, the medical family, the insurance industry and the health IT sector are all working together collaboratively. This type of collaboration is hard and requires great effort, but it is working, and its momentum is increasing.
As Congress begins to write a health IT bill, it is critical that it be crafted in a way that does not interrupt this success by imposing government controls. Government has to be at the table as a full participant, but if the bill prescribes the way these standards are to be set, or puts in place a politically controlled process that picks winners and losers, it will devastate a healthy but fragile process and lose three years of maturity and momentum.
I would offer three principles to members of Congress in dealing with legislation:
First, let’s protect the flexibility of those who are working to invent new tools, and let’s not undermine the work on AHIC that is already underway. Writing legislation to bias the process in one direction or another will constrict innovation and slow the process.
Second, let’s not try to solve all the privacy challenges of the 21st century in a health IT bill. We have to be careful to avoid penalizing early adoption.
Third, let’s respect the need for legitimate healthcare communications. We have to find the balance here. It is in the patient’s best interest for doctors and the patient to have information.
The most important thing government can do is adopt the standards ourselves. The adoption of standards by Medicare, the Veterans Administration, the Department of Defense, and Indian Health, is critical.
We’re making progress on health information technology. Let’s make sure that any legislation accelerates the progress already under way, rather than chilling it with requirements that the government dictate one-size-fits-all answers.
Now here's a healthcare story that deserves to be on Page One.
Hepatitis C, investigators report that they have developed the first tissue culture of regular human liver cells that can imitate infections with the hepatitis C virus (HCV).
"This is the first efficient and consistent model system for HCV to be developed," Martina Buck, assistant professor of medicine at the University of California, San Diego, School of Medicine, who developed the culture, said in a university news release. "There is a need for new treatments, and for development of a possible vaccine for HCV. Now we have a model system to support work by investigators in this area."
Some 170 million people worldwide are infected with hepatitis C, which affects the liver. In the
The virus is usually transmitted by sharing intravenous drug needles and through sexual contact.
Right now, there is no animal model to test different therapies, according to background information in a paper published in the July 16 issue of PLoS ONE.
The therapy can also cause severe flu-like symptoms.
Researchers have so far been hampered in their efforts to understand HCV, because it hasn't been possible to infect normal human liver cells in a laboratory setting.
The new culture allows scientists to directly infect cells with virus from the blood of HCV-infected patients.
A few things:
First, the cut was inflated by those want to kill MA because it was a departure from the government run Medicare program. By pitting doctors against the HMOs it achieved what pitting kids against HMOs didn't do in expanding SCHIP since, as most people have forgotten, the MA payments were going to fund health insurance for kids. So much for the Hobbesian choice.
Second, these cuts will hurt seniors directly and soon. HMOs had to use the extra payments to bring in the sicker and more chronically ill patients and get them healthier...which is what health care is supposed to do. They did so with lower premiums, more care and better disease management. As Mark McClellan noted in Congressional testimony;
Overall, compared to fee-for-service Medicare, beneficiaries in Medicare Advantage plans have much lower out-of-pocket costs; they receive significantly more preventive benefits, drug coverage, and services to help them better manage their chronic diseases; they have very high satisfaction rates; and in most cases, their overall care costs (Medicare plus beneficiary) are lower.
For example, Medicare Advantage beneficiaries
For example, Medicare Advantage beneficiaries receive preventive services like mammograms, colorectal cancer screening, prostate screening, and immunizations at significantly higher rates than beneficiaries in traditional fee-for-service (FFS) Medicare.
In addition, compared to other Medicare beneficiaries without supplemental “Medigap” coverage, MA beneficiaries are only one-third as likely (6 percent versus 17 percent) to report delaying the use of needed care due to cost.1
MA beneficiaries also receive higher quality of care in many areas; for example, a study in the Journal of the American Medical Association found that beneficiaries in MA plans received higher quality of care than beneficiaries in traditional FFS Medicare in five of seven HEDIS quality measures studied.2 Quality is reflected in overall high beneficiary satisfaction rates with their coverage: Consumer Assessment of Health Plans Surveys (CAHPS) generally rate MA plans highest among a range of types of health plans.3
These quality of care results are the consequence of how most MA plans provide coverage. Plans receive a single, risk-adjusted payment from Medicare, and they compete to attract and keep beneficiaries by using this subsidy to provide the most attractive benefits at the lowest overall cost. In contrast, in traditional FFS Medicare, benefits are determined by statute and cannot easily include many innovative approaches to benefit design, provider payment, care coordination services, and personalized support for beneficiaries. Through MA plans, beneficiaries across the country have access to plans with lower or zero copays for preventive services; they have widespread acces to wellness programs; they have access to dental and vision services that not only reduce costs but also help beneficiaries live better and improve their overall health.
Importantly, MA plans are also providing drug coverage that is more extensive and much less costly than in traditional FFS Medicare. This difference in generosity and cost, which increased between 2006 and 2007 and may continue to increase in the future, is likely the result of several factors. First, most MA plans can manage the use of prescription drugs more effectively, as part of their efforts to support the overall coordination of care for a patient’s health. Second, higher compliance with drugs has been shown to reduce other health care costs,4 and because MA plans have incentives to keep overall costs down that do not exist in traditional FFS, they can capture the savings in hospital, physician, and other costs from the greater compliance that comes with more comprehensive drug coverage. Again, this is a more efficient approach to health care coverage.
Finally, most MA plans provide much more support for patients with chronic diseases than is available in traditional FFS Medicare. This is critically important, since the vast majority of costs in Medicare – and most of the cost growth in Medicare – relates to treating the complications of a limited number of serious chronic diseases. Our health care system has huge and persisting quality gaps in the prevention and treatment of chronic diseases. There is no population in this country that needs such personalized services to improve coordination and prevent complications from chronic diseases more than Medicare beneficiaries.
All of these features – better preventive care, lower out-of-pocket costs, better drug coverage, better support for quality care for chronic diseases – are signs of more efficient health care. Not surprisingly, they add up to very large savings for beneficiaries – on average, out-of-pocket costs are $86 a month less in MA, compared to traditional FFS. Medicare with Medigap (counting beneficiary premiums) or no supplemental coverage. That’s more than $1000 a year in savings. This is why a recent analysis by Adam Atherly and Ken Thorpe of Emory University concluded that even though MA payments increase Medicare costs, “the size of the increase in costs will be less than the value of the supplemental benefits provided to beneficiaries” – that is, overall costs to beneficiaries and the Federal government are lower in the MA plans.5 (Similarly, according to MedPAC testimony before the Ways and Means Committee in May, average bids across all Medicare Advantage plans for Part A and B services are lower than the average cost of traditional FFS Medicare6 - and when Part D benefits are included, the cost differences are larger.)
Now all this value in health care will dry up. Republicans -- at least those that voted against robbing seniors of better care to finance a short term extortion of doctors who are already being screwed by Medicare -- should make this a campaign issue.
Do we really want our health care decisions to be run from Washington?
From today's edition of the NY Sun:
Insurers Pay Doctors To Push Generic Drugs
Some Physicians Resist Incentives While Taking Payments From Prescription Firms
By E.B. SOLOMONT,
Two New York health insurance companies are rewarding doctors with cash incentives for prescribing generic drugs.
The companies, Excellus Blue Cross Blue Shield of Rochester, NY and Independent Health, based in Buffalo, are offering higher compensation to doctors who increase their rates of prescribing generics instead of more expensive brand-name medications. The companies say the programs were designed to control the escalating cost of pharmaceuticals and to pass on savings to the patients.
Doctors say that generics sometimes can be safely substituted for brand-name drugs. But some of them also are skeptical of the payments from insurers, saying they could raise ethical questions and even jeopardize the safety of some patients.
"By offering incentives to prescribe generics, there's at least the appearance for an ethical conflict, steering toward the cheaper medication," an Albany cardiologist, Dr. Mikhail Torosoff, said. "That's upsetting."
Insurers defend the practice as a way to rein in costs.
"What we're focusing on here is how do we make health insurance more affordable, and one way of doing that is to promote more cost-effective health care treatments," the senior vice president of the New York Health Plan Association, Leslie Moran, said.
She dismissed the notion that physicians are being coerced. "Everyone likes to talk about the availability and accessibility of health care," she said, "but you can't expand access if its not affordable. A key component of affordability are costs like prescription costs."
Similar programs elsewhere in the country have come under fire. In Michigan, lawmakers and physician groups opposed an incentive program launched by a subsidiary of Blue Cross Blue Shield of Michigan, Blue Care Network, which ran a three-month program that paid doctors $100 for each patient who switched to a generic cholesterol-lowering medication from a brand-name drug.
In response to the backlash, the American Medical Association posted a position statement on its Web site that reads: "A physician accepting payment from an insurer in exchange for moving a patient from a brand name to a generic drug could potentially face both criminal and civil liability exposure under the federal antikickback statute."
Generic drugs that are approved by the Food and Drug Administration must be the "bioequivalent" to their brand-name counterparts, meaning their active ingredients must be the same, drug experts said.
But some doctors said they are wary about switching the drug regimens of patients who are doing well. Prescribing a different drug within the same class could harm a patient, some said.
"The more serious the drug, the more concerned I am about forced substitution," an associate professor at NYU School of Medicine, Dr. Marc Siegel, said.
In New York, the incentive programs offer doctors increased reimbursement if they change their prescribing habits. Under Independent Health's program, doctors who increase the rate at which they prescribe generics receive a cash reward based on their patient base. A physician who increases their rate to 70% from 40%, for example, would receive fifty cents each month for each Independent Health member whom they treat.
Under the Excellus plan, doctors who increase their ratio of generic drug prescriptions to brand-name ones by 5% receive higher reimbursement for patient office visits. The company declined to provide further details on how much doctors are paid, citing proprietary reasons, but officials said the overall goal of the program is to encourage patients and physicians to consider generics.
Officials from Independent Health said their program seeks to educate patients, but they are also rewarding doctors for doing the "extra work" associated with discussing generics with their patients. "Like it or not, physicians are in a business," the company's vice president of pharmacy services, John Rodgers, said.
Other health insurance companies denied plans to launch similar programs. But doctors said a number of companies issue "report cards" that include a tally of the prescriptions that physicians write.
At least one company, Cigna, said it issues quarterly reports to physicians as part of a "Save with Generics" program, which seeks to promote the use of generics by informing patients and doctors how much money they could have saved by avoiding costly brand-name drugs.
"The only purpose is to inform physicians of opportunities to help their patients save money on their prescription medications," the director of public relations for Cigna, Lindsay Shearer, wrote in an e-mail message.
Physicians said the letters and faxes they routinely receive from insurers, which inform them when they could have saved their patients money, amount to unwanted pressure to choose generics. Other tactics used by insurance companies to reduce costs include requiring patients to obtain prior authorization for more expensive drugs, drawing up "preferred" lists of medications, and placing medicines in tiers based on cost and requiring patients to pay more for certain drugs.
"This clearly puts the burden on the doctors to 'fall in line' with the prescribing wishes of the companies," a Manhattan cardiologist, Dr. Adam Deutsch, said.
Dr. Deutsch said most of the time there is no medical reason why a generic cannot be substituted for a brand-name drug. "In all honesty, there's like seven cholesterol drugs on the market. Does it matter? No, it doesn't," he said. "The key is interference. Why is this multi-billion dollar company writing me a letter about my relationship with my patient? To me, it's an ethical issue, not a clinical one."
In recent years, doctors have been scrutinized for accepting drug samples and free lunches from pharmaceutical companies. Both practices are common, and doctors interviewed for this article said they have accepted such gifts. But they distinguished accepting drug samples and lunches from cash incentives by describing the cash incentives as bribes.
Dr. Torosoff, the Albany cardiologist, said he has been paid to speak at events sponsored by drug companies. He declined to say how much he was compensated, but he said the practice is different from accepting a cash incentive from an insurance company because as a lecturer he is performing a service and because he only lectures on FDA-approved drugs and their intended uses.
Dr. Torosoff said pharmaceutical companies have also funded research at the hospital where he works, Albany Medical Center, but he defended such grants by saying he did not personally benefit from them. Regarding the free lunches he has accepted from drug companies in the past, he described the meals as an "advertising" opportunity for pharmaceutical companies. "It's laughable to think I will prescribe something that is harmful to my patients because I got a five-dollar lunch," he said.
Officials from the state's medical society said their position is clear regarding financial incentives given to doctors who prescribe generics: A doctor's primary focus should be on their patient's welfare. "I don't criticize the insurance companies for wanting to contain costs, that's a laudable goal," the executive vice president of the Medical Society of the State of New York, Rick Abrams, said. But he said when conversion is done solely for purposes of cost and not quality, "then we have a severe problem with a program like that."
At least one New York lawmaker, a state senator of the Bronx, Jeff Klein, is proposing legislation that would require all medically necessary prescriptions to be covered by insurance companies. In May, Mr. Klein's office published a report that identified widespread restrictions placed on drug coverage by 19 health maintenance organizations in New York. Of the drugs surveyed, Lipitor, which is used to lower cholesterol, and Singulair, a medication for asthmatics, were the most restricted. Eight companies restricted Lipitor's use, and 11 companies limited Singulair's use.
Mr. Klein said restrictions do not benefit consumers, particularly those who take "single-source" medications, or drugs without a generic equivalent. "They're making it difficult for people to get the drugs they need," Mr. Klein said.
After all, “importation” is, ultimately, the importation of foreign price controls.
Oh yes – and then there are all of those pesty safety questions.
Drat those unintended consequences. So inconvenient for political rhetoric.
According to a letter released by Senator Grassley's office: "I have it on good authority that money from device companies can corrupt research and actually turn devices and procedures such a bypass surgery ineffective. There are serious questions as to whether or not Dr. DeBakey's devices were actually needed and whether bypass surgery is truly safe and effective. Indeed, there are questions as to whether Dr. DeBakey actually existed at all..."
As with other Gardiner Harris articles, the article on Dr. DeBakey consists of:
1. A leaked letter from Senator Grassley's office that is quoted uncritically
2. Linked in ad hominem fashion to other "scandals" such as a device manufacturer giving hospitals grants which in no way are related to Dr. DeBakey but Harris wrote about and since he is too lazy to do real reporting he recycles the material
3. Quotes from critics who never met Dr. DeBakey but hate industry in general and are on Harris' speed dial.
Grassley's office has issued a subpoena to Dr. DeBakey requesting he provide information relating to "all fees received from all device companies during periods specified by this office." When reminded that Dr. DeBakey was deceased, Senator Grassley remarked: "That in itself is no excuse for evading the wrath and reach of my office. Does anyone know if DeBakey was actually a ministry?
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.
