Latest Drugwonks' Blog
A three-judge panel of the U.S. Court of Appeals for the 2nd Circuit said Vermont’s law that restricts companies' use of information about the drugs doctors prescribe is unconstitutional on free speech grounds.
In a 2-1 ruling, the New York appeals court said the law doesn't achieve what Vermont wants to achieve and that a more limited restriction would be better.
"The state has not demonstrated that its interests in protecting public health and containing health care costs could not be as well served by a more limited restriction on speech," the majority opinion said.
But there’s more to this issue than Free Speech. There’s also a crucial safety component.
When FDA-directed safety warnings are issued, they're communicated via "Dear Doctor" letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans - developed for physicians who prescribe higher-risk therapies - are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), "Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others."
Relative to physician concern that their prescribing data will be used for aggressive marketing campaigns, the AMA has a web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing-data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA's program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Senator John Barrasso, M.D.: “I am thankful to have 13 new Republicans in the Senate to help repeal and replace Obamacare.”
Nancy-Ann DeParle: “I’m thankful for my wonderful family, having more time to see them and the chance to implement a law that is delivering real relief to millions of Americans.”
From the pages of Medical Marketing & Media:
Patients taking a medication and looking online for health information tend to avoid pharmaceutical company sites, according to an online survey conducted by Accenture.
Just over two-thirds of surveyed respondents said they go online for health information, according to the data. Of that group, nearly half (48%) said they use medical websites like WebMD most often, and just 6% said they use social media sites like Facebook or Twitter most often for health information. Eleven percent of the respondents said they use a pharma company website most often – the same percentage that reported using an online community, like a disease-specific patient site, most often.
Tom Schwenger, global managing director for Accenture's Life Sciences sales and marketing practice, said he “acknowledges the regulatory hurdles that exist in two-way dialogue” between pharmaceutical companies and patients, but that “the gap between the hurdles and what we're seeing represents a large opportunity” for pharma marketers. “What's ironic is that industry cost pressures are greater than ever before, so it makes sense to reevaluate digital and online strategies” with respect to patient communications, said Schwenger.
The survey also found that 69% of respondents “expect pharmaceutical companies to provide information about an illness or condition,” and only 28% of respondents said they are more likely to ask their doctor about a drug after seeing an advertisement. However, 46% of respondents said drug ads increased their awareness of symptoms and possible treatments. Ten percent of respondents said their drug choice had been influenced by coupons, and 47% said it had not, but could be in the future, according to survey data.
The survey's sample was 852 adults in the US, and was conducted between August 30 and September 3, 2010.
At a recent meeting of the Generic Pharmaceutical Association, CDER Director Janet Woodcock said that the FDA is discussing tightening the equivalence limits of generic medicines "so there is less variability.”
In April, the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, voted 11-2 that the agency’s equivalence requirements aren’t’ sufficient for certain medicines. They didn’t offer an alternative, and suggested the FDA list “critical dose drugs or drugs where a small difference in concentration can change patients’ reaction, that may need new standards.
The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs do constitute a distinct group and voted unanimously that FDA should develop a formal list of those drugs - although the terminology of "narrow therapeutic index" may be more appropriate. And in an 11-2 vote, the committee concluded that current bioequivalence standards are not sufficient for drugs in the narrow therapeutic index group.
Critical dose drugs have a narrow therapeutic index, meaning that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions." FDA is consulting the committee on the need to establish separate bioequivalence criteria for these drugs given continuing debate about whether critical-dose drugs require special consideration, the agency explained.
(Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.)
Last month the FDA responded to a request from New Jersey State Senator Joseph Vitale concerning pending New Jersey state legislation that, if enacted, would require pharmacists to dispense epilepsy drugs from the same manufacturer as previously dispensed for certain patients, unless otherwise prescribed.
In its response to Senator Vitale, FDA comments that “[t]o date, we have not seen any scientific evidence that demonstrates a problem with therapeutic equivalence for this group of products or any other class of generic drug products. Those who are questioning the quality of generic epilepsy products have produced only anecdotal evidence.”
And, further:
“[W]e believe that the concerns of some of those raising questions (in particular, physician groups) cannot be dismissed lightly. Because of FDA’s respect for these groups and the concern that patients may lose confidence in their prescribed medications, we have sought to conduct further study. Our decision to further study this issue does not stem from doubt within the agency about data we currently have on approved generic epilepsy products. Rather, it is based on a desire to obtain further independent scientific evidence that might address these concerns.”
Condescending? I suppose it depends how you choose to read it. Does the agency really mean to dismiss the concerns of practicing physicians who see these problems first hand? Maybe PDUFA V funds should be earmarked for FDA staff to attend more neurology conferences to hear about the "scientific evidence” first hand.
More peculiar still is that such statements seem at total counterpoint to the comments of Dr. Woodcock and the unambiguous votes of the advisory committee.
This strikes a very personal note for me. One of my sons has Juvenile Myoclonic Epilepsy. His condition is wonderfully controlled via his meds – and I’d like it to stay that way.
"This drug doesn't work. Period. It just doesn't work," said Steven Nissen, head of cardiology at the Cleveland Clinic. U.S. Rep. Bart Stupak, a Michigan Democrat helping to lead a congressional investigation of the study, said, "It is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data." Investors voted with their feet, pushing Schering-Plough (nyse: SGP - news - people ) shares down 8% and Merck (nyse: MRK - news - people ) shares off 1%. "
www.forbes.com/2008/01/14/enhance-merck-schering-biz-healthcare-cx_mh_0115bizenhance.html
Oops that was 2008, when Nissen was leading the charge and making charges that a study about Vytorin was flawed and that the two companies were engaged in -- what else -- a coverup of the shoddy research and its conclusions. At least that was the narrative shaping the stories from Matt Herper, Steve Nissen's Boswell... Here is a laundry list of Matt's articles regarding the 'coverup' of the Vytorin debacle.
| Sept. 3, 2008: Top Statistician Says Vytorin Cancer Risk 'Not Ruled Out' |
| May 19, 2008: Should Schering-Plough's Chief Give Back His Bonus? |
| April 15, 2008: Vytorin's Man In The Middle |
| March 30, 2008: Vytorin Backlash |
| March 25, 2008: More Questions About Vytorin Panel |
| March 21, 2008: Vytorin On Trial |
| Jan. 11, 2008: Inside Schering And Merck's Secret Panel |
| Nov. 19, 2007: The Vytorin Question |
Herper went so far as to misconstrue Eric Topol's measured response to the study: One person who won't be convinced by ENHANCE: Eric Topol, the noted chief of translational medicine at Scripps Health in La Jolla, Calif. He still wants to see clear data on how Zetia affects heart attacks, strokes and deaths, and doesn't understand why it took so long to embark on a big study to prove it. Doctors have been "hanging in suspense for years, unnecessarily," Topol says. "It's still conceivable there would be improvement in outcomes. Until we have that data, the jury is out."
Dr. Topol emphasized the need for a larger study with outcomes data. The recent study about Vytorin is consistent with Topol's broader work on genomics and heart disease:
That driving down LDL alone is not sufficient for reducing the risk of stroke or invasive procedures in both primary care and high-risk populations. Further, the mechanism by which Vytorin did achieve a reduction in plaque build up and stroke are still not completely clear. LDL levels fell but it will be interesting to see how that decline is biologically linked with the clinical outcomes observed. Finally, linking hard clinical endpoints to reductions in plaque remains an exciting and interesting area of research in cardiology when paired with genomic research that can tailor treatments to populations with different forms of the disease.
And what did Nissen say about the SHARP results? Matt Herper channel's him:
"Without a group of patients who received just Zocor, it’s impossible to determine whether Vytorin worked any better than Zocor would have alone, says Steven Nissen of the Cleveland Clinic, another critic of the drug. "blogs.forbes.com/matthewherper/2010/11/20/finally-a-win-for-vytorin/
But let's repeart what Peter Kim said:" the investigational use of the drug significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease -- and this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
Anyone who has been diagnosed with cancer knows the importance of having an arsenal of therapeutic weaponry. So why are federal officials asking patients with advanced breast cancer to unilaterally disarm?
The weapon in jeopardy is Avastin, a biologic drug that cuts off the blood supply to tumors. Clinical studies prove that for women with stage 4 breast cancer, Avastin buys them weeks or months in which the cancer doesn't spread.
But the Food and Drug Administration isn't satisfied this time is “enough,” and will decide by Dec. 17 whether to revoke its approval of Avastin as a treatment for breast cancer.
Patients and their doctors have proclaimed they should decide what constitutes “enough.” Cancer treatment can't be one-size-fits-all. Some research has found, on average, Avastin doesn't prolong life. But scientists universally agree that it does prolong the quality of life. One study demonstrated that Avastin plus chemotherapy delayed tumor growth a median of about 11 months — five months longer than chemo alone.
Focusing only on averages ignores patients that are “super-responders.” Erin Howarth, was 31 when she learned her stage 4 breast cancer had spread to her spine, skull, pelvis and right leg.
“I got the impression that it was just like, ‘Well, you're going to come here for chemo every week . kind of until you die,'” Howarth told a newspaper.
But she sought out other doctors who put her on Avastin. Within seven months, her cancer was in remission. Labeling herself the poster child for Avastin, she concluded “it worked really well for me.”
Susan G. Komen for the Cure and Ovarian Cancer National Alliance wrote to the FDA urging them to preserve Avastin. They contended that removing it from the FDA's list of approved drugs for breast cancer could discourage future drug development.
Since the FDA fast-tracked approval of Avastin two years ago, it has been prescribed to about 17,500 patients a year with metastatic breast cancer.
This summer, a 13-member FDA advisory panel — with only two breast cancer oncologists — recommended that the FDA withdraw its approval of Avastin for breast cancer patients.
Doctors could still prescribe Avastin without FDA approval by going “off label.” But if the FDA revokes its breast cancer seal of approval for Avastin — insurance companies, Medicaid and Medicare are also likely to deny coverage.
The latest vote of confidence in Avastin comes from the National Comprehensive Cancer Network — a not-for-profit alliance of nearly two dozen of the world's top cancer centers. Last month, they announced it had reviewed and affirmed its guidelines for using Avastin to treat metastatic breast cancer.
The FDA should listen to these experts, and to patients. Avastin may well be the best weapon they've got to fight cancer — and the government shouldn't take it out of their hands.
Actions have consequences – often unintended ones. And the same is true for inaction.
Remember the medical device “gap” of the 1990s? That’s when Europe was outpacing the United States in bringing new medical technologies to market. Well – the gap is back, it’s growing – and it has consequences.
The #1 consequence is that Americans don’t have access to new technologies that make a difference. It also means that American companies (and their investors) wonder whether continued investment in research and development is worth it.
And what’s on the other side of the equation? One would think, well, safety. After all, nobody wants the FDA to approve unsafe medical technologies. Sure enough. But there’s no evidence that these newer options available in Europe are anything except safe and effective. Hence, there is a gap in care but none is device safety. What’s wrong with this picture?
All this while we debate reform to (among other things) the 510(k) process. Reform? Good. Better? Sure. But we must also address the issues of better with faster. We must learn from Europe. We must harmonize with Europe. And we mustn’t ignore the reality that the medical technology gap is widening and that this fact has consequences for the public health in the United States today as well as for the competitiveness of the American medical technology industry in the future.
A new survey of medical technology companies and investors (by Josh Makower, MD Consulting Professor of Medicine, Stanford University; Aabed Meer MD-MBA, and Lyn Denend Research Associate, Stanford University – with support from the Medical Device Manufacturers Association, the National Venture Capital Association, and multiple state medical industry organizations) is important reading -- and not just for industry and investors, but for thought leaders and policy makers – and especially those at CDRH.
The full report can be found here.
Don Berwick's coming out party was a little over an hour long. He was shepherded and sheltered by Finance Committee Dems who ate up the clock with softball questions about how Obamacare repeal would affect seniors. Berwick said disastrous without explaining how stoping cuts in hospice care and Medicare advantage and using comparative effectiveness to delay access to breakthroughs like Provenge are harmful. Republicans didn't even have enough time to clear their throats before the hearing was adjourned.
Berwick recycled comments he has made since the story about his love affair with rationing, centralized decisioning making and the NHS was broke by yours truly: He told the Committee seniors should get "all the care they want and need, when and where they want and need it."
He didn't mention that what people want and need will be limited by what government defines as quality care.
And he already broke his promise by delaying access to Provenge and rationing diabetes strips.
Read Linda’s entire blog post here.
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.
