Latest Drugwonks' Blog
"...recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do. Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills."
www.nytimes.com/2009/09/26/health/26contracept.html
Hmm...
Here's a blog from a law firm leading the litigation against Bayer, the company that makes Yaz:
"The risks associated with this popular birth control pill are severe; many women who took Yaz or Yasmin have died or been seriously injured because of the serious health risks associated with the drug. In fact, the FDA received over fifty reports of Yaz and Yasmin-related deaths between 2004 and 2008, most involving increased levels of potassium and occurring in women as young as 17 years old. Imagine how many went unreported! A growing number of lawsuits have been filed by or on behalf of these women, charging the drug manufacturer with inadequately warning them of the increased risks Yaz and Yasmin pose to those women who use the oral contraceptive.
While the public-at-large and many physicians may not recognize an adverse reaction to drospirenone, the health risks have been known for longer than many realize. In 2002, the British Medical Journal reported some practitioners’ concern about the drug as a result of 40 cases of venous thrombosis among women taking it. Also, in 2003, the Journal published a paper that detailed reports of thromboembolism deaths and injuries thought to be caused by Yaz and Yasmin.
www.nolan-law.com/yasmin-yaz-ocella-birth-control-injuries/#side%20effects
The FDA has been reprimanding Yaz and Yasmin manufacturers for misleading and inadequate television advertising for the drug for quite some time."
Here's Singer again... stoking the fires, fanning the flames, leading the witness...
"The health questions and the lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer’s approach to complying with government rules, said Michael A. Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry. "
False Claims Act anyone? That's the fulcrum which the trial lawyers use to leverage meager findings about safety into a conspiracy of silence and misrepresentation.
I see another Avandia in the making.
Via the Pink Sheet:
The potential for physicians to favor innovator biologics over follow-on biologics because of a reimbursement advantage would be eliminated under an amendment to health care reform legislation adopted by the Senate Finance Committee Sept. 23.
The amendment, offered by Sen. Charles Schumer, D-N.Y., says the goal is "to ensure that patients and the Medicare program utilize biosimilars appropriately" and "create parity between brand name biologics and biosimilars and save patients and Medicare money."
The basic problem the amendment is trying to solve is the fact that, under current law, each biological product must have a separate billing code for reimbursement by Medicare Part B. Since the reimbursement rate under Part B is the average sales price of the drug plus six percent, if a biosimilar were introduced at a lower price than the innovator, there would be no incentive for physicians to use the lower-priced drug, since the six percent administration payment would be higher for the innovator. As a result, there would be no downward pressure on prices.
To eliminate this disparity, the amendment would provide equal administration fees for both the innovator, or reference product, and the follow-on biologic. The description of the amendment says a biosimilar approved by FDA and assigned a separate billing code would be "reimbursed at the ASP of the biosimilar plus six percent of the ASP of the reference product."
Brand Pharma May Dodge A CBO Bullet
The committee adopted the amendment by unanimous voice vote, and brand pharma stalwarts Sens. Orrin Hatch, R-Utah, and Michael Enzi, R-Wyo., joined as co-sponsors.
Brands may be supportive of the idea of reimbursement parity for physicians because, if treated as the fix Medicare needs to accommodate FOBs, it would mean that brands avoided potentially much more consequential modifications to the program.
The Congressional Budget Office has previously suggested that there would be additional savings from follow-on biologics if they are put on equal footing with innovators in government health care programs, not just in terms of physician reimbursement, but product coding as well, which would mean that brands would be reimbursed at the FOB price.
In a December 2008 score of legislation options, CBO said that putting a biosimilar in the same reimbursement code as its brand-name counterpart would save the government $10.6 billion over 10 years, about 30 percent more than the $8.1 billion it would save if they were not in the same code.
Many observers believe that such a coding change would need to be made by statute, and that without it Medicare would never fully embrace FOBs. Indeed, while the Schumer amendment removes a disincentive to prescribing FOBs, it does not seem to create an incentive for their use either.
Dr. Alway concludes by boiling the entire debate down to two choices before us:
For the sake of future Americans, let us hope and pray that we take the first road.
"People have unique needs. I take Lipitor, they put me on the generic, Zocor, my cholesterol went up. They put me back on Lipitor, my cholesterol went down."
You mean that all statins aren't the same? That different people respond to different drugs in different ways. That generic substitution can have ... unintended consequences? Holy cow! And who is the mysterious "they" the Senator refers to? Probably not his Uncle Sam.
(PS, "Zocor" is not the "generic." Simvastatin is the generic. Not the same thing. But that's another story for another time.)
FDA NEWS RELEASE
For Immediate Release: Sept. 23, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:
* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.
Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.
As part of the study, the IOM will convene a committee to answer two principal questions:
* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?
The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:
* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.
The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
Which is also one reason why insurance under the health care proposals are 3 times more expensive than are available in the marketplace.
The other reason: legislation is nothing but a huge subsidy to large corporations, most union benefits and the liberal imagination. Heaven forbid, people choose health plans with higher deductibles, lower premiums, less coverage than the micromanagers want us to have.
On a related note: Here's President Obama's OMB director on what is really happening to health care costs:
"On the consumer side, and despite media portrayals to the contrary, the share of health care expenditures paid out of pocket, which is the relevant factor for evaluating the degree to which consumers are faced with cost sharing, has plummeted over the past few decades, from about 33% in 1975 to 15% today. All available evidence suggests that lower cost sharing increases health care spending overall. The result is that collectively we all pay a higher burden, although the evidence is somewhat mixed on the precise magnitude of the effect."
Rather than allowing people to choose plans that allow for cost sharing and accumulate cash (especially important for people who are chronically ill) and include health insurance premiums to lock in rates and pay for one time costs Orszag endorses the current solution: using an expert panel to determine what doctors should do and how much they should get paid for it:
"The real traction, though, will come from building the results of that research into financial incentives for providers. In other words, if we move from a “fee-for-service” to a “fee-for-value” system, where higher-value care is awarded with stronger financial incentives and low- or negative-value health care is penalized with smaller incentives or perhaps even penalties, the effects would be maximized."
All of which is at the heart of the Baucus bill and every other piece of legislation. Well since CER has been implemented elsewhere and costs have gone up, what has been the result on patients? Dr. Orszag let's it slip:
"... if all one did was, say, reduce payment rates under Medicare and Medicaid, and then tried to perpetuate that over time without a slowing of overall health care cost growth, the result would probably be that fewer doctors would accept Medicare and Medicaid patients, creating an access problem that would be inconsistent with the underlying premise and public understanding of these programs."
www.issues.org/24.3/orszag.html
Which brings us back to Newt. All of this happens because of government control. The unintended consequences of government run health care.
We may disagree with the Obama vision of health care but we also share his commissoner's vision of how to sustain medical innovation.
Watch Commissioner Hamburg's remarks here.
According to Senate leadership aides, Senate Majority Leader Reid may bring a bill to the Senate floor in the next two weeks that would allow the importation of prescription drugs from Canada.
Wonder if Senator Reid has discussed this act of pharmaceutical imperialism with our neighbors to the North. Last conversation I had with Canadian officials left no doubt they are very concerned with how such an action would impact their domestic medicines supply.
And is this bill about drugs from Canada or drugs through Canada?
Here we go again.
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.
