Latest Drugwonks' Blog
Pfizer has received European approval to expand the use of its pneumococcal conjugate vaccine Prevenar 13 to adults aged 18 to 49 years for the prevention of invasive pneumococcal disease, according to a company statement.
The vaccine, which protects against 13 strains of Streptococcus pneumoniae, is approved in the European Union (EU), the United States, and elsewhere for use in infants, young children, and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older.
"Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood." the company said in the statement.
The European Commission's decision to expand use of the vaccine to 18- to 49-year-olds followed the submission and review of data from an open-label phase 3 trial of the vaccine in healthy adults in this age group, the company said.
The study, which met all primary and secondary objectives, showed that the vaccine is at least as immunogenic in this age group as it is in adults aged 60 to 64 years, as measured 1 month after vaccination. Prevenar 13 showed a favorable safety profile and was generally well-tolerated.
"Adults aged 18 to 49 years with certain underlying medical conditions may benefit in particular from vaccination with Prevenar 13 because of an increased risk of pneumococcal disease," said Luis Jodar, PhD, vice president of the Vaccines Global Medicines Development Group at Pfizer.
Prevenar 13 (known as Prevnar 13 in the United States, Canada, and Taiwan) is now approved in more than 120 countries worldwide for use in infants and young children, as well as in more than 80 countries for use in adults 50 years of age and older.
But not approved for scheduling in the United States (beyond patients who are immunocompromised or over age 65). What’s wrong with this picture?
On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.
(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)
And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Not so fast.
Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients. That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).
ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”
The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.
In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.
The need for this patient population exists. The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.
The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia
"It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their own interest." - Adam Smith
Good reporting from MedPage Today – demonstrating once again that, when it comes to lowering healthcare costs and improving healthcare outcomes, the free market trumps Big Government.
More Choice More Common in Medicaid Plans
States are increasingly moving to privatized managed care programs for their Medicaid recipients as state lawmakers look to change the safety-net system despite objections from naysayers, members of Congress were told Monday.
Kansas, Louisiana, and, most recently, Florida have received federal OKs to offer expanded managed care programs that allow patients to choose from a list of plans with varying benefits.
"The states set the floor of the benefits on those plans, but then the plans can add additional benefits on top of that using the savings they create by better coordinating care," Tarren Bragdon, chief executive of Foundation for Government Accountability, a conservative think tank in Naples, Fla, said after a House Energy and Commerce Health Subcommittee hearing Monday examining Medicaid.
Privatized plans include traditional Medicaid managed care programs and provider-driven plans. Florida, which had its federal waiver approved last month, offered 13 plans and 31 benefit packages in its five-county pilot program, Bragdon said.
"Patients like this choice, with 70% to 80% of Medicaid patients proactively choosing the plan rather than being automatically assigned to one," Bragdon told lawmakers.
States spend between a quarter and a third of their budgets on Medicaid, surpassing the amount spent on education, and they can expect that amount to grow under the Affordable Care Act's expansion program, which opens the program up to all those making up to 138% of the federal poverty level.
States like Florida, Louisiana, and Kansas can expect to save money, Bragdon said, making states like North Carolina, Texas, and Utah consider similar moves. The states believe they can generate greater savings through managed care for more expensive patient groups like the elderly and disabled.
The plans have risk-adjusted capitated rates so they earn more money to enroll sicker patients and have incentives to improve patients' health, Bragdon said. Competing for enrollment, plans are forced to improve benefit packages and improve access to specialists. Plans must publicly report outcomes and conduct consumer-satisfaction surveys annually.
In Louisiana, patients have the choice to opt back to traditional Medicaid. But of 900,000 Medicaid patients, only 3,000 took that option.
"The Florida reform pilot outperformed on health outcomes in 64% of the cases," Bragdon said.
But opponents of privatizing Medicaid cite a lack of accountability over the plans.
"The pilot program for Medicaid privatization [in Florida] was known as a real disaster," Rep. Kathy Castor (D-Fla.) said during Monday's hearing. "The state's own study condemned the results."
Several plans dropped out of the pilot citing an inability to make money, and patients complained of bouncing from plan to plan creating lapses in care.
She called the final waiver approved for the state-wide program "night and day" different from the pilot. The statewide program has new consumer protections, penalties for providers who back out, and medical loss ratios, Castor said.
"While these programs have been controversial in some instances, they reflect a desire by states to utilize care coordination and care management methods and move away from Medicaid's fee-for-service history," Alan Weil, executive director of the National Academy for State Health Policy in Portland, Maine, told lawmakers.
All but three states have at least some Medicaid managed care in their state, and Weil said two-thirds of Medicaid patients receive most or all of their benefits through managed care.
"States are increasingly relying on mandatory managed care programs in Medicaid for more complex populations such as children with special healthcare needs and people of all ages with a variety of healthcare needs," Weil said.
The lack of clinically useful diagnostics is hindering the growth of personalized medicine.
According to research by the Tufts Center for the Study of Drug Development, without clinically useful diagnostics, personalized medicine growth will occur at a relatively slow pace.
And personalized medicine represents the future of healthcare around the world.
That’s why the recent CMS decision to deny coverage for contrast-enhanced PET scans is a disturbing harbinger of the continued battle between short-term cost concerns on the one side and long-term patient care and medical innovation on the other.
CMS released a draft decision memo indicating that Medicare would pay for contrast-enhanced PET scans aimed at visualizing beta-amyloid protein plaques in patients brains only in the context of rigorous clinical trials, under the agency's "coverage with evidence development" (CED) policy.
The Alzheimer's Association said it was "disappointed" by the government's tentative decision last week not to allow broad Medicare coverage for brain amyloid imaging.
"With 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical," the group said in a statement.
The Alzheimer's Association noted that, in the past, it has taken as long as 7 years for CMS to move from a CED designation for new medical technologies to full coverage.
"The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic," the group's statement said.
Eli Lilly & Co., which sells the only currently approved PET contrast agent (AmyVid), said it was disappointed in the CMS's draft decision memo, as did the Medical Imaging and Technology Alliance.
All three organizations pointed to "appropriate use criteria" published earlier this year by an expert panel that backed clinical use of the technology in select patient groups.
The panel, convened by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, said PET amyloid scans would be appropriate for patients with unexplained cognitive impairments, those with tentative Alzheimer's disease diagnoses who show unusual clinical presentations, and those with progressive dementia occurring before age 65.
The Alzheimer Association and Lilly noted that the memo is currently open for public comment (through August 2) and that CMS could still decide to allow broader coverage.
Let’s cut to the chase, if we are going to take meaningful strides both in addressing Alzheimer’s Disease specifically and in personalized medicine more broadly, we should not rely on Coverage with Evidence Development (CED) criteria in cases where the FDA’s approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population.
Fact: The evidence on amyloid imaging supports coverage for the population as identified by the Amyloid Imaging Task Force through Appropriate Use Criteria (AUC). A task force, convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, recommends coverage in this population based on a comprehensive review of the literature and expert consensus.
Fact: CMS currently covers similar PET technologies to aid in the diagnosis of Alzheimer’s Disease and other forms of cognitive decline. The agency has not previously required evidence of health outcome improvement as a condition of such coverage.
Fact: Using CED alone will deny Medicare beneficiaries adequate and rapid access to this technology, as the path to implementation is unclear. Such uncertainty in the reimbursement process strongly dis-incentivizes future investments in research and development. And without innovation there will not be advances in personalized medicine.
Wither “sustainable innovation?”
Why even bother with expedited review and similar FDA pathways? Clearly closer FDA/CMS coordination is required to address both the will of Congress – and the future of American healthcare.
What's on your list of FDA spending priorities? According to report in the Pink Sheet, the Wizards of White Oak are currently spending just south of $10,000,000 on 11 research projects -- including a $2 million study of online prescription drug promotion.
According to OPDP panjandrum Tom Abrams, “Our objective as an agency is to increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions.”
First let’s look at the record.
OPDP receives 6,000 to 8,000 advertising and promotional submissions each month, which are assigned to one of OPDP’s 32 reviewers. Per Tom Abrams, the office gets about 120 complaints about promotional materials each year from physicians, consumers and pharmaceutical companies, and of these about 45 concern DTC ads. In 2012, OPDP issued 10 untitled and warning letters for DTC promotions.
Are 10 letters worth $10,000,000 in sparse agency resources? Well, where you stand depends on where you sit.
In the view of Jeff Francer, PhRMA’s assistant general counsel, research activity is taking place “when many stakeholders are asking for regulatory guidance.” There is a “question as to how OPDP is spending its resources.”
As for the value of FDA’s DTC ad research, Francer said it is unclear to him what benefit it provides.
That’s a fair question. If, as Tom Abrams said, the objective of the studies (and hence the justification for the spending) is to “increase the quality of DTC ads so they do not contain any misleading information and instead provide patients with good information about prescription drugs and medical conditions,” then why isn’t the agency working with industry (where the expertise and experience resides) rather than going it alone? If the goal is to increase compliance, then why research rather than better guidance (per Francer)?
Tom Abrams equates “increased quality” with accurate, non-misleading information. And that’s important. But it’s the second part of his definition that should provide a pause for reflection. Consider, “ … instead provide patients with good information about prescription drugs and medical conditions.” Many (if not all) companies that advertise prescription drugs would (and should) argue that their advertisements do precisely that.
Can industry do better? Yes. Should they do better? Yes. Will these OPDP studies help them do better? That’s the question on the table – and it’s an open one.
At the end of the day, “in compliance” and “in the best interests of the public health” must not be mutually exclusive – indeed they should me mutually supportive.
Where will the FDA’s 10,000,000 take us? Will they be a turning point, resulting in pharmaceutical companies’ embracing an educational public health imperative and allotting more media dollars for help-seeking advertising? Or will they be a tipping point, with politicians and the public zeroing in on aggressively targeted DTC in print, on TV … and online?
Working together with industry, FDA can make a difference. Together, industry and FDA can evolve DTC communications into a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because “an educated consumer is our best customer.”
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FDA DTC Advertising Research Projects Underway |
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|
Project |
Cost |
Objective |
|
Quantitative Effectiveness Information in Television and Print Advertisements |
$1,026,555 |
Examine whether adding placebo information and whether changing the framing of the information helps consumers understand risk information. Also examine how physicians use the prescribing information documents and assess efficacy information. |
|
Composite Scores |
$356,082 |
Determine whether consumers understand composite scores (overall score of drug’s affect on multiple symptoms) as currently communicated and how best to communicate these scores to lay audiences.
|
|
Disease Information in Branded Promotional Material |
$1,500,000 |
Investigate the effects of adding disease information to promotional materials on consumer perceptions and understanding. |
|
Effect of Promotional Offers in Print Advertisements on Consumer Product Perceptions |
$924,365 |
Examine what impact, if any, the presence of coupons in DTC ads may have on consumers’ recall and perceptions of product risks and benefits, and the overall impression of the product in full-product and reminder ads. |
|
Comparative Advertising |
$1,482,034 |
Determine how consumers interpret and react to DTC comparative drug ads. |
|
Corrective Television Advertising |
$386,286 |
Evaluate how corrective DTC Rx drug advertisements impact consumer perceptions |
|
Online Promotion |
$2,019,620 |
Test different ways of presenting Rx drug risk and benefit information on branded drug websites. |
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Brief Summary Format Variations in Print Advertisements |
$296,509 |
Determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. |
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Healthcare Professional Survey |
$364,588 |
Follow-up to 2002 physician survey, it is designed to explore the opinions and perceptions of physicians, physician assistants and nurse practitioners regarding promotion of Rx drugs to consumers and health care providers. |
|
Patient Information Prototypes |
$1,613,294 |
Test two different formats for presenting patient medication information to patients when they retrieve their prescriptions. |
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Risk and Benefit Perception Scale Development Focus Groups |
Not Available |
Develop and validate risk and benefit perception scales and explore various methods for measuring recall and comprehension. |
ObamaCare's 'Liar' Subsidies
The White House says you can sign up 'without further verification.'
The White House seems to regard laws as mere suggestions, including the laws it helped to write. On the heels of last week's one-year suspension of the Affordable Care Act's employer mandate to offer insurance to workers, the Administration is now waiving a new batch of its own ObamaCare prescriptions.
These disclosures arrived inside a 606-page catch-all final rule that the Health and Human Services Department published on July 5—a classic Friday news dump, with extra credit for the holiday weekend. HHS now says it will no longer attempt to verify individual eligibility for insurance subsidies and instead will rely on self-reporting, with minimal efforts to verify if the information consumers provide is accurate.
Remember "liar loans," the low- or no-documentation mortgages that took borrowers at their word without checking pay stubs or W-2s? ObamaCare is now on the same honor system, with taxpayers in tow.
People are supposed to receive subsidies only if their employer does not provide federally approved health benefits. Since HHS now won't require business to report those benefits or enforce the standards until 2015, it says it can't ask ObamaCare's "exchange" bureaucracies to certify who qualifies either.
HHS calls this "a slight technical correction" though it is much more than that. The exchanges will not only start dispensing benefits "based on an applicant's attestation" about his employment insurance status. HHS is also handing the exchanges "temporarily expanded discretion to accept an attestation of projected annual household income without further verification."
In other words, anyone can receive subsidies tied to income without judging the income they declare against the income data the Internal Revenue Service collects. This change has nothing to do with the employer mandate, even tangentially. HHS is disowning eligibility quality control because pre-clearance is "not feasible" as a result of "operational barriers" and "a large amount of systems development on both the state and federal side, which cannot occur in time for October 1, 2013."
You've got to love that passive voice. It's true that coordinating and managing vast amounts of information from hundreds of millions of Americans and corporations, and monitoring compliance with more than 10,000 pages of fine-print Federal Register regulations so far, is hard to do. Yet that is the system Democrats installed when they passed the law, which is not supposed to be optional due to administrative incompetence.
HHS promises to develop "a more robust verification process," some day, but the result starting in October may be millions of people getting subsidies who don't legally qualify. This would mean huge increases in ObamaCare spending. Some of these folks could be fraudsters, much as 21% to 25% of Earned Income Tax Credits flow to people who aren't eligible, according to the Treasury inspector general. The same error rate for ObamaCare would amount to as much as $250 billion in improper payments in its first decade.
The irony in the case of ObamaCare is that liberal health policy is predicated on the notion that if Congress commands something on paper, it will happen in the real world. Architects Peter Orszag and Ezekiel Emanuel are still claiming against all evidence that their policy experiments in human behavior modification will yield huge cost savings.
Yet now we are discovering that Democrats passed a bill that is so large and convoluted that even they can't implement it in practice. So don't be surprised if millions of individuals decide they're eligible for the subsidies, or should be, and wait for someone eventually to say they aren't.
Liberals are also now claiming that the employer mandate and these eligibility rules were never important parts of ObamaCare. This is revisionist history, not least because the mandate and eligibility limits helped reduce the cost as measured by the Congressional Budget Office.
The revisionism is also false because every provision of ObamaCare is supposed to "solve" a problem created by some other provision of the bill. Kick out one of the struts like the business mandate and the whole apparatus becomes even more unstable. In the case of the lawless decision to shelve any income or employer insurance scrutiny, HHS's logistical challenges are real. But our bet is that the Administration is also using them as a pretense in a deliberate bid to make it much easier to join the exchanges.
That's because the health planners are terrified that enough healthy, low-cost people won't sign up and therefore the Affordable Care Act's strict regulations on underwriting and risk-pooling will blow up insurance markets. As more and more of ObamaCare tumbles, the Administration is resorting to anything that can salvage the goal of permanently expanding the U.S. entitlement state.
All of this fits with ObamaCare's entire bloody-minded history. Democrats were determined to make their rendezvous with the liberal destiny of government-run health care, so they imposed this debacle on the country on a partisan vote and despite public opposition. Now that they are discovering how difficult it is to remake one-sixth of the U.S. economy, they are rewriting the law as they go and telling Americans they have no choice but to live with the consequences.
Since the Supreme Court’s recent 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett established that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the question on the lips of safety cognoscenti has been, “wither generic drug safety?”
The Supreme Court’s decision pushed to the head of the line concerns over bioequivalence, Narrow Therapeutic Index and – as biosimilars become a part of the conversation -- therapeutic interchangeability.
Well on Wednesday (yes, the very day before the Fourth of July holiday), the FDA posted a notice on the OMB website that it plans to published a proposed rule to “create parity” between generic and innovator drugs relative to how they update their labels. Buried treasure.
(Under current FDA regulations, generic manufacturers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.)
The FDA’s new proposal would also address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.
According to a report in the New York Times, the Generic Pharmaceutical Association had “no comment.”
And that’s a shame – because this presents the manufacturers of generic medicines with a timely opportunity to step up to the plate and become a player (rather than a problem) when it comes to both cGMPs, quality, and safety.
Hopefully, upon return from the long weekend, generic drug manufacturers will embrace the FDA’s proposals.
We shall see.
You cannot escape the responsibility of tomorrow by evading it today.
-- Abraham Lincoln
BioCentury reports that the European Commission published an interim set of rules that would establish a permanent, voluntary network of EU member states to facilitate cooperation and sharing of information for health technology assessments (HTAs). Member states must send written notice to the EC to participate in the network, which will comprise the national authorities responsible for HTAs in each participating state. The EC will manage the network, which also will support the European Network for Health Technology Assessment (EUnetHTA) consortium. EUnetHTA is a group of government-appointed organizations, regional agencies and not-for-profits that produce or contribute to HTAs in 29 European countries, including 26 EU member states.
Last May in Moscow, I heard Hans Severens (Erasmus University) speak about “the possibilities and the impossibilities of HTA.” His main point (which became a mantra of all of the day’s presentations) is that, when it comes to HTA, “all decision-making must be made in a local context.” He also firmly stated that economic concerns are only one of many petals on the HTA flower – another point reinforced throughout the course of the program. Countries “shouldn’t just adopt NICE findings” but should assemble all available information and put all data into a local context.
If all politics is local – so to must HTA designs and decisions.
Hello PCORI!
Solid directional guidance fom Bob Hugin, CEO of Celgene and the new Chairman of PhRMA.
Supporting the ecosystem of medical innovation is the most important thing we can do to improve health care for patients with unmet medical needs in the United States.
Medical innovation is a crown jewel of America and its economy. It has been the greatest source of longer life and economic prosperity in our country and around the world. In the course of just one decade, from 1999 to 2008, medical innovation brought about a 45 percent reduction in deaths from cardiovascular disease. Biopharmaceutical therapy for a devastating disease like Alzheimer’s can reduce nursing home admissions by 50 percent. HIV has gone from an untreatable, fatal disease to a serious but manageable condition. And in cancer, nearly 50 million life-years have been saved for patients since 1990 because of innovative approaches to cancer prevention and treatment.
How did we accomplish this? By working together – large and small companies, academic researchers, government agencies, and patient organizations alike. By taking risks and investing in innovation. And those investments have paid off in scientific advancement and economic growth. For example, the US government spent $3.8 billion over thirteen years investing in the Human Genome Project, generating enormous private sector activity. Every $1 invested in the Human Genome Project created $140 in economic value, repaying the government for its investment via tax revenue many times over, and producing transformative scientific and medical advances for patients.
We cannot take this ecosystem for granted. In fact, it is very much at risk. Short-sighted policies that limit scientific and medical innovation today could negatively affect patients for decades in the future. Consider Alzheimer’s Disease. The Alzheimer’s Association reports that without new disease-modifying treatments, by 2050, at least 13.5 million Americans will have developed Alzheimer’s disease, costing this country $1 trillion per year – a crushing expense. A new therapy that delays the onset of Alzheimer’s by five years would reduce by nearly 45% the number of people with the disease by 2050, and save $447 billion per year. We cannot afford NOT to invest in the discovery and development of such a potential treatment today.
So how do we protect the ecosystem of medical innovation? Fortunately, while the challenges are greater than ever, so too are the opportunities. We are only at the early stages of being able to capitalize on the revolution in molecular biology and information technology. With more than 5,000 new treatments in development, the promise and potential of recent scientific and technological advances is enormous. We must be bold and courageous and stay focused on developing innovations that meet patients’ most pressing unmet needs. And to do this, we must have a policy environment that supports innovation, values the entire ecosystem of medical progress – academic medical centers, voluntary health associations, government agencies like the FDA, CMS and NIH, and, crucially, the biopharmaceutical company scientists, entrepreneurs and investors responsible for discovering, developing and bringing to patients the vast majority of new treatments.
Part of a supportive environment for innovation is ensuring that patients have access to the most innovative treatments. New therapies that reduce hospitalizations, promote productivity and improve quality of life have the potential to make real reductions in the overall cost of health care, but access to these treatments is critical. Medicare Part D is an example of how the public and private sectors can work together to maximize benefit to patients and value to society. This government supported, privately delivered program based on competition and choice has expanded access for good prescription coverage to 30 million seniors, with 90 percent satisfaction among participants, at a cost more than 40 percent lower than projections, and substantial demonstrated savings in other parts of the medical system. We must work to protect this model and also ensure patient access to therapeutics in Medicare Part B, other government-funded health programs, and in plans offered through health exchanges.
We can improve health care in the United States by fostering a policy environment that strengthens the ecosystem of innovation, so that working together, we can pursue bold innovations that create longer life and better health for patients.
"Dr. Doshi’s renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world’s biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public."
You see, his renown comes froms digging up old data and proving that Steve Nissen and Andrew Wakefield were right all along!!
"He met Dr. Jefferson, a prominent skeptic of the flu vaccine, after researching whether the Centers for Disease Control was exaggerating the deadliness of the disease.
“We were both lone wolves in the field of influenza,” Dr. Doshi recalled.
Just great. Wakefield redux and the NYT believes that undermining the support for immunization is a important as curing cancer!
Transparency is a tool for people who hate the drug industry to make challenges based on statistical manipulation of data sets... Avandia and Paxil are great drugs for the right people and have saved lives. The second guessing has lead to both medicines being underused while treatments that have even clearer adverse events have been overprescribed. I have seen what researchers have done with the data.. Tamiflu works brilliantly for a subset of patients. The problems it now has is that the viral strains it was designed to block are mutating.
Moreover, what is submitted to the FDA and peer -reviewed publications has nothing to do with financial ties and everything to do with the exclusion criteria and the way studies are conducted. What do these guys contribute to improving or moving the ball forward towards personalized medicine...nothing. Anyone who claims that these drugs DONT work are liars and building their reputations on the bodies of people who are dead because they bought the bullshit. That goes for Ben Goldacre in particular who seems to get off on making TED speeches.
Datasharing that re-examines hypothesis or established science should be encouraged. But it has to be conducted as if people's lives are at stake. I hate to say it, but this is the kind of ass kissing 'stick it to the man' bias that allowed Wakefield to spread fear about vaccines.. Do you think the NYT would have ran the story if it was about giving a medicine a second life for dying patients? And would these 'whistleblowers' have gone after a company that pulled a drug working in a sub-group.
It seems that lately, when it comes to healthcare policy, we are living in the land of unintended consequences.
Per the Supreme Court’s recent 5-4 decision that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the one-eyed man is measuring the throne room.
Writing for the majority, Mr. Justice Alito opines that state law cannot trump federal laws regarding prescription medicines whose design has been approved by the Food and Drug Administration. So, the obvious first question is, why doesn’t Federal Preemption hold for innovator products. Will the Court revisit Wyeth v. Levine? Not likely.
And then there’s the more important question – that of patient safety. While there is no language in the Supreme Court decision on either bioequivalence or therapeutic interchangeability, the unintended consequence of their decision is that many payers and physicians, now that the burden of potential legal entanglements has been lifted, will now consider generics as “the same” as their innovator forefathers and prescribe accordingly.
And since the Supremes’ made no special mention of Narrow Therapeutic Index, well, Katie un-bar the door for anti-seizure meds, anti-depressants, etc.
Not good.
The Court’s decision also undermines the urgency of educating payers, physicians, and patients on the subject of generic drug quality – and this goes further than just excipient changes.
It’s one of our nation’s most important and yet invisible problems. How to educate the various relevant publics on “bioequivalence?” Not that we were trying very hard before – but as we approach the reality of both small molecule patent expiry and biosimilars, the issue becomes less and less academic and more and more practical.
For example, how will the Court’s decision impact the INN debate?
The Court’s decision has thrown yet another cloak of invisibility over the urgent need for quality maximization.
William Gladstone famously said that, “Justice delayed is justice denied.” Well, getting the right medicine to the right patient at the right time (as good a definition as any of “personalized medicine”) is healthcare justice – and the Supreme Court’s decision is going to be a barrier to achieving justice for all.
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.
