Latest Drugwonks' Blog
For those of you who missed Latin class that day, memento mori means, “remember your mortality.”
It seems that the American Medical Association has (albeit a little late in the game) woken up to that fact and gotten religion.
The AMA has invited other healthcare groups to sign onto a letter to the Patient Centered Outcomes Research Institute (PCORI) on the types of research that should and should not be conducted under ObamaCare. The AMA is concerned about its proposal to "investigate ... optimizing outcomes while addressing burden to individuals, resources, and other stakeholder perspectives."
They should have read the bill before they so aggressively supported its passage.
Why the turnaround? Could it be that America’s physicians worry that including cost in the equation will open the door to rationing down the line?
"We seek further clarification toward the Board's intentions regarding this last component and whether this includes cost analysis," states a sign-on letter scheduled to be sent later this week to PCORI executive director Joseph Selby. "If that is the case, we do not believe that it is consistent with the PCORI's enabling statute."
The issue, at its core, is physician disempowerment. With first insurance companies and now Uncle Sam telling doctors how to practice medicine (step therapy, restrictive formularies, more strident and cumbersome preauthorization requirements, and academic detailing), it’s no wonder that physicians are mad and that the AMA is doing a volte-face on PCORI and comparative effectiveness.
My good friend, Professor Meir Pugatch of the University of Haifa, is one of the world’s most respected experts in the role that robust intellectual protection plays in economic development.
In a new paper in the Journal of Commercial Biotechnology, Dr. Pugatch asks a crucial question -- To what extent does the strengthening of intellectual property (IP) environments in developing countries lead to greater in-flows of technology transfer in these countries?
According to Dr. Pugatch, there is a growing body of statistical evidence suggesting that a stronger IP environment does contribute to an enhanced level of foreign direct investment (FDI) and technology transfer in developing countries.
For example, an OECD study ï¬nds that in developing countries an increase of 1 per cent in the strength of patent rights resulted in 1.7 per cent increase in FDI flows, which in turn resulted in the transfer of know-how, that is innovative capabilities. Quite an attractive multiplier.
Here’s the official abstract:
The strength of pharmaceutical IPRs vis-à-vis foreign direct investment in clinical research: Preliminary findings
This article examines the effect of the intellectual property (IP) environment in developing countries on the level of foreign direct investment (FDI) and technology transfer occurring in the biopharmaceutical field in these countries. In particular, it considers the correlation between the strength of IP protection in several developing countries (using the Pharmaceutical IP Index) and the number of clinical trials taking place in these countries (as a proxy of biomedical FDI). The article finds that overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.
The full article can be accessed here.
As the recent Institute of Medicine report concludes the scientific evidence about vaccines benefits and microscopic risks is clear and convincing. Report: Vaccines Are Safe, Hazards Few And Far Between
Yet, politicians of all stripes have indirectly fed the the unfounded fear of parents who refuse to vaccinate, thereby endangering the lives of others. the Obama administration has ducked the issue of vaccine safety instead of addressing the issue clearly.. It has missed several opportunities to promote vaccine safety and have, in the past, caved into anti-vaccine forces. It has given money to anti-vaccine groups. At the same time it was unfortunate that Rick Perry backtracked on the issue of requiring HPV vaccination, not because mandatory vaccination is appropriate (it should be used sparingly) but because in doing so he did not reaffirm the importance of the vaccine in eradicating many forms of cancer that are increasing in prevalence. And Washington State, where parents are refusing to immunize their kids in record numbers, has buckled under pressure for anti-vaccine forces and failed to enact a law making it tougher to bail out of vaccinations. www.kvewtv.com/article/2011/aug/01/wa-leads-nation-parents-opting-out-immunizations/
For many reasons lots of politicians don't want to say they support a government requirement of any form. (The battle over the individual health mandate is a case in point.) And they don't want to confront parents who insist vaccines cause autism. But requiring people to be immunized is a way of protecting the freedom not to be exposed to vaccine preventable illnesses. Many, if not most, of those who are infected by vaccine choicers and their kids, are infants or immunocompromised children who rely upon others to protect them against disease and death.
Freedom is not the unfettered right to avoid the dangers dancing in your head at the expense of the health and life of others. Living in and benefitting from a free society requires not just meeting obligations but also abiding by norms of thought and collective action that comport with reason and science. Thomas Jefferson observed: "The value of science to a republican people, the security it gives to liberty by enlightening the minds of its citizens, the protection it affords against foreign power, the virtue it inculcates, the just emulation of the distinction it confers on nations foremost in it; in short, its identification with power, morals, order and happiness (which merits to it premiums of encouragement rather than repressive taxes), are considerations [that should] always [be] present and [bear] with their just weight."
Politicians and public health officials should stand up for medical science and not contribute to what the National Vaccine Advisory Committee calls "the culture of refusal."
They single out any relationship involving any resource or transaction that "may" have a monetary value exchanged between drug or device companies and academics.
But health IT companies, HMOs, trial lawyers, hospitals, government bureaucrats who hand out dough for comparative effectiveness research are exempt from oversight. Apparently there is no possibility for any undue influence from such entities.
The NIH are defensive about the impact these regs will have on innovation. And they should be.
"We want to emphasize that the revisions are not designed to prevent or hinder relationships among government, academia, and industry. Rather,
the revisions are aimed at facilitating such relationships by increasing transparency and accountability so that the resulting research is considered objective and in the interest of the public."
Given that most scientific misconduct and publication bias is a product of career climbing having nothing to do with industry, the emphasis on industry seems misplaced.
Moreover, who said that people are concerned about objectivity as defined by the Obama administration? One person's objectivity is another person's bias. And the new regs simple open up the process of biomedical innovation to more questions about conflict that have nothing to do with quality of the research -- ultimately measured by whether we can prevent or control diseases more effectively -- but everything to do with the cultural and ideological belief that commercialization inherently benefits large companies at the expense of the rest of us and that the commercialization process is inherently corrupt and corrupting.
The advocates of the regs claim that more oversight and investigation is needed because industry support for research has increased. Is it the industry support itself or the magnitude? Where is the evidence that more money means more corruption? Isn't the opposite outcome as likely: That is, people with a financial stake in the outcome of a research are more likely to be more scrupulous about research to protect their investment? Loss of reputation is a huge price to pay for fudging data for starters. Do the NIH reg advocates believe that industry funded scientists are more likely to lie about the safety and effectiveness of new products even at the expense of harming people?
The answer is yes. This culture of mistrust would have ensnared and persecuted the following individuals who had -- under the new guidelines -- the potential or actual presence of a financial conflict:
Louis Pasteur -- wine and beer maker and recipient of wine industry money
Gertrude Elion
George Hitchings
Sir James Black
Craig Zello
Phil Sharp
Joseph Goldstein
SIr Peter Mansfield
Judah Folkman
Most are Nobel Prize winners. All used industry money to commercialize devices and medicines that have extended and improved life. But according to the conflict of interest priesthood, the research they produced was tainted and therefore the results could be not trusted. They would be required to "report the name of the company or entity in which there’s a conflict of interest, the value of the interest, why it’s a conflict and “some key elements” of how the institution plans to manage the conflict."
blogs.wsj.com/health/2011/08/23/new-nih-conflict-of-interest-rules-better-than-the-old-rules/
Note there is no room for arguing there is no conflict. It's a confict. Acting as if it isn't is a grounds for investigation. Your only option is to tell the world just how guilty are are or appear to be. This makes a forced confession easy by comparison.
Meanwhile Andrew Wakefield, who received cash from trial lawyers and his own patients, would be exempt not only from the new NIH rules but the suspicion of the COI kapos.
Ditto the groups who pushed for this sort of witchhunt. Money from George Soros, the IOM (a conduit for ideologically tilting foundations) and others are exempt too.
The new rules are the culmination of an ideological assault by those who believe commercialization is inherently corrupt and corrupting and who ignore the fact that as a result of such innovation, life expectancy and death rates from cancer, heart disease and other illnesses have declined in direct relation to the industrial investment in treatments for death and disease.
Google Inc. has agreed to pay $500 million for carrying advertisements by online Canadian pharmacies targeting consumers in the United States, according to the U.S. Justice Department.
The ads resulted in the illegal importation of prescription drugs, the Justice Department said.
That's a big oops.
The $500 million represents the money Google made from selling the drug ads, plus the revenue earned by Canadian pharmacies from sales to American customers.
As an FDA Associate Commissioner said back in 2003 (on the front page of the Washington Post), "You can't blame them (Google) for accepting commerce. But they really haven't understood the consequences."
They do now.
Who was that prescient FDA guy?
For the answer to that question and further background on this story, see here.
Guidances are okay but they are no substitute for less regulation and more scienced-based common sense, as evidenced by this account of how farmers may soon have to regulate...dust.
blog.heritage.org/2011/08/20/president-obamas-regulatory-dust-up/
Call it Obamacare's Final Destination Tour. While President Obama rests up at Martha’s Vineyard, people whose lives should be saved by new and existing cancer drugs are driving from hospital to hospital in search of medicines in short supply thanks in part to Obamacare’s implementation.
Over the past two years shortages have developed for over 180 drugs, including cancer treatments. The shortfall is the result stricter FDA regulation, government price controls on already discounted but complex drugs, and policies that discourage the use of new medications. Companies, facing lower prices, tighter regulation and increasing government control over what drugs will be used when, are exiting the US market and investing in product development in china and India where, sadly, it is easier and cheaper to produce next generation medicines than in America.
Stockpiling will only add to people's suffering by replacing market reforms with government micromanagement. Government planners require months, if not years, to produce regulations, bids and supply estimates that are usually overgenerous to compensate for paltry prices. Government bungling was behind the failure of the smallpox and H1N1 vaccine program and responsible for billions of dollars in flu vaccines and antibiotics being dumped.
The same forces pushing stockpiling also believe commercializing medical discoveries is evil. It’s part of a larger effort to nationalize the development of medicines that under Obamacare is become institutionalized
Indeed, the drug shortage is a product of a more troubling trend: At a time when medical research could yield breakthroughs in the treatment of obesity, Alzheimer's, diabetes, stroke among others, innovation has all but dried up. Most of the medicines being used today were developed 30 years ago. Most of them have generic competition. They have contributed greatly to increased wellbeing but as the return on generic drugs fall, price controls and regulation have created shortages.
Obamacare is making the commercialization of newer drugs and devices more difficult.
Though new and faster methods to determine a technology's safety and effectiveness exist, Obama’s FDA still demands evidence collected with science and statistical methods developed in the 19th century. To be sure, in the last two years new medicines for AIDS, cancer, lupus and hepatitis have been developed. Yet, these products should have been available sooner if not for FDA nitpicking.
And now that they are finally approved, patients are finding it next to impossible to access several new drugs and genetic tests that would transform the quality of life and extend survival for such illnesses as lupus, prostate cancer and organ transplantation.
Provenge, the first cancer vaccine, stalled at the FDA for years. Once approved, it faced 18 months of additional delay while the Obama administration figured out whether to pay for it. The gauntlet cancer patients face with Provenge is being extended to everyone waiting for a medical breakthrough under Obamacare: Before a medical innovation can be used or paid for the government will now demand additional research demonstrating that a new product will be more effective and cheaper than existing technologies. Since most new products come from small start-ups with limited cash, such a requirement means live saving innovations will not be available at all.
Similar regulations have been used to delay and deny access to cancer drugs in England, Canada and Australia. Drugs such as Avastin, Revlimid and Herceptin are barely used in Britain's cancer wards because government decided they were not valuable. The people who could not use them are dead. Those -- mostly in America -- that did are alive.
But now this de facto rationing is coming to America. Before the cancer drug shortage there was the decision that women under 50 should not get mammograms. Both Provenge and Benlysta, new treatments for prostate cancer and lupus respectively, are hard to come by because of uncertainty about reimbursement by health plans and government. .
The death and suffering flowing from such delays are the result of policies promoted by those who want to use the FDA and increased government control over medicine to slash access to new technologies. In their mind, rationing of cancer drugs frees up money to expand the welfare state. The shortage of old drugs is simply one side effect of this malevolent strategy.
It would be simpler to claw back regulations and let markets work. But stockpiling is part of a larger effort to centralize the development and use of medical services. The administration has gone silent on the wonders of obamacare even as it issues regulations and hires bureaucrats to replace free choice with government edict. But it will emerge as a campaign and social issue. In America no one should go without medicine because they can't afford it. And it shouldn’t be a nation where people are denied such treatments because their government makes medicine impossible to produce or obtain.
I am currently attending (and speaking at) the Technology Policy Institute’s annual Aspen Forum. It’s refreshing to listen to presentations on issues other than healthcare. But, on the other hand, there are a lot of parallels.
One disturbing similarity was brought to mind by a talk given by FCC Commissioner Robert McDowell. The topic was regulation of the Internet. McDowell commented that he wasn’t sure when the question of “Should the Internet be regulated?” morphed into “How should the Internet be regulated?
And he was very clear that this was a disturbing “iterative change.”
Sound familiar? We should be asking ourselves the same thing about comparative effectiveness. When did “Should we adopt a national comparative effectiveness approach to healthcare?” morph into “How should we adopt a national approach to comparative effectiveness?”
There’s still time and opportunity to robustly debate the former so that we can avoid the latter.
We can, in the words of Commissioner McDowell, “avoid a race to the bottom.”The Generic Pharmaceutical Association never misses an opportunity to miss an opportunity. They are balking at continuing to negotiate the design of a biosimilar user fee program that is independent of other user fees and has its own baseline appropriations trigger.
The disagreement stems from a proposal by GPhA and a representative of potential biosimilar sponsor Momenta Pharmaceuticals that biosimilar reviews remain part of the Prescription Drug User Fee program through fiscal year 2017, the end of the first biosimilar program cycle, according to minutes of a July 18 meeting.
The tactic could be a way to lower the cost of a biosimilar application. If the agency is forced to include biosimilars in the PDUFA program, it likely would have a more difficult time arguing it needed a strong funding base to ensure the program functions properly.
GPhA said it could not continue “detailed negotiations regarding volumes and metrics without agreement to parity with the PDUFA user fee program.”
The position would seem to reverse one taken during a July 11 negotiation. Minutes indicated “industry stakeholders” and FDA agreed to support a flat product development fee of about 10% of the marketing application fee for the fiscal year while a biosimilar product was in the IND stage.
It is unclear whether FDA could send a commitment letter to Capitol Hill for approval without support from a major trade group involved in the negotiations.
If FDA went ahead with a commitment letter for a separate biosimilar user fee program and GPhA wanted to press the issue, the generic group would presumably need to convince legislators that its interpretation of the 2007 bill creating the new approval pathway was correct.
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.
