RSS

Category Archives: Opposition to Reform

The Most Interesting Man Revolutionizing The Health World

He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors to air scrubbing systems at his infamous Chicago wine parties. And his mustache rules his twitter feed. In 2013 he was awarded the Star of Distinction, the highest civil award by the Government of Pakistan, for his inventions that are making significant impact in developing countries. He has written over 50 books, well over 100 research papers, and hundreds more articles in the field of science, philosophy, rhetoric, poetry and religion, drawing thousands of hits per day on his blog. Dr. Sarfaraz Niazi might just be the most interesting man in the world, but he is certainly the most interesting man pursuing biosimilars in the United States.

Throughout his career his driving principle has been to make things simpler. He did this while at Abbott Labs, as a former tenured professor at the University of Illinois at Chicago (UIC), in developing countries, and presently in his independent career at Therapeutic Proteins International, LLC (TPI) where he is working on biosimilars – or “copies” of current biologic pharmaceuticals that are about to lose their patents. Although only 17 biosimilars have been approved to date worldwide, though none in US, Dr. Niazi and TPI have nine in the pipeline to transform the entire market.   According to photographer Steve Huff, Dr. Niazi is, “An amazing man, in fact the most interesting man in the world!”

Flexibility Is Key To Innovation

When asked his advice to other inventors in a recent interview, Dr. Niazi explained his philosophy that, “You should never get enamored by your thoughts. If the idea does not solve a problem or move the quality of life farther, there are many more things to be invented.” With that mentality, he is filing two products this year alone, similar to Amgen Inc.’s $6 billion molecule white blood count product, due to its expiring patent in the cancer market. Next year, the two molecules he plans to take to market are similar to AbbVie’s expiring $12 billion product Humira.

With movement like that, it’s no wonder Dr. Niazi claims that the U.S. Food and Drug Administration (FDA) is his “friend.”Nevertheless, he notes extreme complications with the rolling submission model, which can cost up to $4 million per submission in fees alone. Additionally, the four levels of the FDA’s “analytical similarity” benchmarking can be troublesome if one has a new biologic entity. This benchmarking, however, allows scientists and the FDA to work together in a predictable, step-wise fashion to move products to market quickly that have fingerprint-like similarity to existing US-licensed biologic products.

Dr. Niazi’s strategy is to create an analytical and clinical equivalent to biologics with expiring patents, which is preferred even over a Phase 3 clinical trial. By doing this, the cost of production is reduced drastically and the speed of development increases by 2-3 times. Dr. Niazi estimates an overall reduction in production costs for his biosimilars of up to 50% or higher compared to market competitors.

By being flexible, his products are proving to be bio-revolutionary.

Can The United States Catch Up?

Additionally, thanks to the Affordable Care Act (ACA), a shorter licensing path for lower-cost versions of cell-derived drugs is now possible, giving inventors like Dr. Niazi another pathway for approval and distribution.

While he claims that the ACA will not reduce health costs, he does believe that independent shocks to the health market will. By this, he believes that making biosimilars easier, faster, cheaper and better translates directly into his mission of making all things simpler. Further, cost-effectiveness in the US and European Union (EU) can directly convert into worldwide distribution and scalability that is safe.

Although a friend of the FDA, Dr. Niazi is not hesitant to note the tough decisions US-based companies face to stay in the states. Having FDA approval carries weight around the world, but the financial and regulatory burden can be great for inventors and business owners. In contrast, he asserts that the EU has moved ahead of the rest of the world, with the most established and advanced regulatory framework for the authorization and marketing of biosimilars, which has since been adopted by the World Health Organization (WHO).

Additionally, Dr. Niazi says that it is difficult to raise money in the US. Venture capitalists and corporate investors are less likely to take risk and have notoriously poor track records with the health sector

Investing In The Windy City

In 2003, the TPI founder committed that his work and company would stay in Chicago.  He believed that from creation to manufacturing and testing to going to market, that TPI would excel in the Midwest due to Chicago’s health care ecosystem, experts and manufacturers.

Through a focus on creating “generic equivalents,” Dr. Niazi is proving that TPI can be wildly successful in the Midwest, and further, that in the same way generics revolutionized how people access pharmaceuticals, biosimilars can revolutionize the way those around the world access lifesaving treatments.

As his biosimilars enter the market with FDA approval, the ability of Dr. Niazi to impact the entire health sector grows because his biosimilars can be substituted for its reference product without provider or patient intervention. However, the FDA has not yet finalized these guidelines, and only 17 biosimilars have been approved internationally to date, of which none are by the FDA.

Ultimately, with numerous billion-dollar biologics coming off patent over the next six years, and the exorbitant cost for specialty drugs, the nine biosimilars TPI has in the pipeline stand to make a huge impact in the health sector. While Dr. Niazi could be doing many interesting things these days as an international man of mystery, he has devoted his research, time and energy to bringing high quality, cost-effective treatments to the US, and beyond. So long as he maintains his wine parties and poetry readings, its certain no one will complain.

Advertisements
 

Tags: , , , , , , , , , , , , ,

The meaning of success

How should we define the success of the Affordable Care Act (ACA)? In recent months, news reports focused on the number of new enrollees as a key test of the law. Although the troubled performance of the healthcare.gov website during October and November delayed enrollment for hundreds of thousands of potential subscribers, Obama administration officials and Congressional Democrats hailed a surge in enrollment at the end of the year as proof that the law would fulfill its promise of providing affordable coverage to millions of uninsured Americans.

To date, enrollment numbers paint a decidedly mixed portrait of the ACA’s impact. Speaking on September 30, 2013, HHS Secretary Kathleen Sebelius declared that “success looks like at least 7 million people having signed up by the end of March 2014.” By late December, however, Sebelius hailed the fact that 2.1 million people had signed up for coverage through the new exchanges as evidence that the law was now working well. Earlier in the month, President Obama cited the increased pace of enrollment as proof that “the demand is there, and the product is good.” Even the most optimistic estimates, however, suggest that signups continue to lag far behind the administration’s own goals.

Obama administration officials responded to criticism about the widespread cancellation of individual insurance market policies in late 2013 by exempting millions of Americans who faced “unexpected natural or human-caused events” that prevented them from obtaining coverage from the individual mandate. Ironically, this decision, which sought to mollify Congressional critics and their outraged constituents, further undermines the prospects for meeting its enrollment targets and exacerbates an already serious credibility gap for Democratic candidates in the upcoming Congressional elections. Democrats continue to emphasize a “moving average” approach to measuring the success of the health insurance exchanges, pointing out that the pace of enrollments increased steadily once the website’s “glitches” were ironed out in late November. However, a failure to meet the administration’s own goal of 7 million new enrollees by the end of March 2014 will provide Republicans with a new policy story just in time for the 2014 campaign season.

Unfortunately for Congressional Democrats, increased enrollments did little to rehabilitate the image of the ACA in the eyes of the public. In a CNN poll released in on December 23, support for the law fell to 35% – a new low – despite significant improvements to healthcare.gov as a result of the “tech surge” in late November. The new polls highlight a troublesome trend for Democratic candidates who heed President Obama’s call to close ranks behind the ACA. Core Democratic constituencies now oppose the law, including 60% of women. Furthermore, in an ironic twist, 63% of those polled expected to pay more for health care after the implementation of the Affordable Care Act. In its current form, the ACA promises to be a millstone around the necks of vulnerable Congressional Democrats in 2014. Unless the Obama administration and other supporters of reform can reassure a doubtful public about the problem-solving capacity of American political institutions, the ACA may prove to be a classic Pyrrhic victory. In short, administration officials may win small battles over improving the performance of website, but lose the larger war over public support for government-led health care reforms.

The continued unpopularity of ObamaCare more than three and a half years after its enactment reflects a much deeper concern than simply website snafus or insurance cancellations. As I’ve argued elsewhere, ObamaCare has done little to restore public faith in the ability of government to solve social problems. Unless and until the administration begins to meet its own targets, the political fallout of the ACA will cast a long shadow over the 2014 elections … and beyond.

 

What Will You Pay for Insurance Under ObamaCare?

Since it was first debated, one of the major criticisms of ObamaCare was that it was going to make the cost of health insurance skyrocket. And, in turn, many critics of the law who happen to own their own businesses, expressed concern that they would be forced to pass on these higher costs to their consumers. We were told that Papa John’s large pizzas would cost an additional 14 cents because of higher insurance premiums. Consequently, Papa John’s and Applebees—whose CEO is also an outspoken critic of ObamaCare—have seen the public’s opinion of them drop dramatically. Of course, the White House released numbers to dispute the notion that employers would be hiring fewer full-time employees to avoid paying for their health insurance. But the best news of all is that we can stop speculating about what will happen to insurance premiums under ObamaCare, and start looking at actual data.

This is precisely what the non-partisan Kaiser Family Foundation did in a recently released report on 2014 health insurance premiums in 17 states and the District of Columbia. What they found is that health insurance premiums aren’t that high. In fact, they are lower than the Congressional Budget Office projected that they would be. Of course, that doesn’t mean that rates won’t have increased from the year before, as Avik Roy points out in arguing things from the consumer perspective. But Roy also oversimplifies things, because he fails to take into account the net cost to the consumer in light of the fact that many–if not most–Americans, will receive federal subsidies to help them purchase coverage. On this point, Wonkblog’s Sarah Kliff does a terrific job of walking through different scenarios, based on an individual’s age, income level, and choice of insurance plan, to calculate actual monthly premiums in 2014 after the subsidies are taken into account. The news is generally quite good: A 40-year old woman in Seattle earning $28,725 a year will receive a $90 monthly subsidy, which means she can get a silver plan for $193 a month or a bronze plan for $123 a month. As insurance goes, that’s awfully inexpensive. And, Kliff points out, if the same individual was 60-years old, she’d effectively get an even bigger subsidy, worth $408 a month, so that she can get a silver plan for the same $193 a month, but would be able to get a bronze plan for just $44 per month. Folks, that’s $528 a year for health insurance with a 60% actuarial value.

These rates are low, and by October 1, we should have actual premium pricing for all 50 states, so more analyses like these can be done, and we can start outreach and enrollment efforts to educate people about their options and what various insurance products available in their state will cost them. What we won’t exactly know–a point Kliff makes in her own piece–is what people are willing to pay or what they consider “affordable” as the Affordable Care Act has implied care will be. This is more subjective, because it depends on how people prioritize their health, and thus their demand for health insurance, and how they budget the rest of their income. Overall, though, the early news seems positive, and suggests that for many people, affordable health insurance–and the health care it buys–is just a few months away.

 

GOP Governors and the Health Insurance Exchanges

In conservative states, especially those with Republican governors, the pushback against implementation of the Affordable Care Act (ACA), perhaps better known as “ObamaCare,” has been quite notable. In fact, these were the states that joined with Florida in challenging the law before the Supreme Court. Unfortunately for them, they lost their case, at least for the most part. The Court did say that they don’t have to participate in the Medicaid expansion, and most of the GOP governors have declared that that is precisely the path they will take. On another issue, however, the federal government can act if the states do not.

The issue at hand is the establishing of the so-called “health insurance exchanges”–a marketplace for consumers to shop for health insurance coverage on the basis of more transparent premium cost and benefit design. The ACA was written to provide states with flexibility to design their exchanges within broad federal guidelines, with the assumption that state policymakers are more familiar with the specific needs of their state’s residents. This, in fact, is precisely the way that the Medicaid program operates.

However, unlike Medicaid, the ACA put in place a “stop-gap” measure. In the event that states failed to establish their own exchanges, the federal government would establish one for them. In other words, states can design their own exchanges however they would like, provided they meet federal guidelines with respect to minimal acceptable coverage and tiered plan levels. But, if a state says no, Uncle Sam says “Fine. We’ll do it ourselves.” And the state gets no say in the design of that exchange.

And therein lies the irony: Democratic governors in liberal states have gone ahead and established–or are in the process of establishing–their own, state-designed health insurance exchanges. They’ve been able to set up a system that will work best for their residents, and they have been in charge of the entire process. Meanwhile, the Republican governors in conservative states have been defiantly refusing to set up their own exchanges as best they see fit, which, in turn, is an open invitation for the federal government to impose its will on those states. That, of course, is the very thing that they opposed from the outset. You just can’t make this stuff up.

For more on this story, I recommend this article in Politico, as well as this one from USA Today.

 

Why Does John Boehner Want To Increase The Deficit?

We’re in an election year. The economy is less than ideal. The best strategy the GOP can take to win big in 2012 is to say “You’ve had your chance and it didn’t work.” The slogan they’ve been lampooning–“Change we can believe in”–seems to have become their new battle cry. Okay. Fair enough. I’m willing to hear them out. What, pray tell, are the Republicans proposing to do that will make things better for America and its people?

Well, for starters, there’s the important issue of making sure that the wealthiest Americans stay that way. Now, I’m not talking about those people you know who are living quite comfortably. I’m talking about that select group of Americans who are so uber-wealthy that they could, if they felt like it, pay enough money to the right people and take advantage of the right legal loopholes to buy your neighborhood and kick you out of your house against your will. Okay, that might be a bit hyperbolic, but not by much.

The reason, we are told, that the super-rich must continue to receive such preferential tax treatment despite the fact that our nation’s deficit threatens the entire country’s economy, is because these are America’s job creators, and what Americans need more than anything right now are jobs. That, my friends, is called “trickle-down economics” and it hasn’t worked……well…..ever. Warren Buffett is pretty clear on the fact that he is incredibly rich, and that he isn’t in a position to put a dent in the unemployment problem, which is why he wants the wealthiest Americans to stop catching so many breaks and start giving back.

But I’m willing to accept the GOP’s premise here for the sake of argument. Let’s take the raising of increased tax revenue off the table. If we do that, there are only two options left: Cut spending, or fail to reduce the deficit. Republicans and Democrats both agree that we need to reduce the deficit, and we all know how rare bipartisan agreement on anything is these days, so I think it’s safe to say that Republicans should pursue a strategy to cut spending. And, indeed, that’s what they’ve been talking about–and in many ways trying to do. Take health care. Hey seniors, remember that Medicare program you love so much and don’t want government to get involved with? Republicans have proposed that the program be fully privatized and replaced with a voucher system. I hope they decide to write you a big enough check to pay for the care you need. There is little doubt that it will cut spending, but it will also cut your benefits.

Surely it’s better than “Obamacare” you say? That’s why the GOP has promised to repeal and replace the Affordable Care Act if–and this is the catch–you vote for them in November. That’s right, America. Vote for them first, and then keep your fingers crossed that they’ll follow through. After all, it’s not like politicians ever fail to fulfill their campaign promises. I mean, the GOP is doing its part to show how committed they are to the idea. They’ve voted to repeal the ACA 33 times since it was enacted. It hasn’t gone anywhere, but hey, they tried. But I digress. The point is that repealing the Affordable Care Act will be a step in the right direction. It will keep the Democrats’ hands off your Medicare, so that Republicans can destroy that program later, and it will cut costs. Deficit problem solved. Except for one thing. The Congressional Budget Office just wrote a nice letter to Speaker of the House John Boehner explaining that repealing the Affordable Care Act will actually increase the federal deficit by $109 billion over the next decade. As Rick Perry would say, “Oops.”

So, when you head to the polls this November, ask yourself why, if Republicans are so intent on reducing the deficit, they intend to repeal a law that would do just that? Why, in fact, would they insist on preserving tax cuts on the wealthiest Americans and passing a bill that will not only dismantle improvements to our health care system for the most vulnerable Americans, but actually raise the federal deficit in the process? I mean, it’s one thing for fat cat Republicans to cut benefits for the poor to save money. Now they’re actually talking about cutting benefits for the poor to spend money. It doesn’t make sense. But then again, if it gets you to vote for them, it doesn’t have to.

 

Medicaid and Red State Governors: A Love/Hate Relationship

In addition to the much discussed individual mandate, a central element of the Affordable Care Act designed to increase insurance coverage is the expansion of the Medicaid program to cover anyone with an income up to 138% of the federal poverty level. To put that into context for those who might not know, Medicaid eligibility currently has two requirements: income eligibility and categorical eligibility. Income eligibility means that your income has to fall below a certain level, which varies by state within certain federal guidelines. Categorical eligibility, which also varies somewhat by state, means that you have to be a certain “type” of person. For example, pregnant women and children are typically eligible for Medicaid, whereas very few childless adults are eligible. The Affordable Care Act changes that, making anyone who is low-income (again, 138% of poverty, or $30,843 a year for a family of four) eligible regardless of what other “category” they might belong to.

The odd thing about the ACA, though, is that it will actually be more generous to conservative states that have not previously established more generous Medicaid limits. Here’s why: Starting in 2014, the federal government will pay 100% of the difference between what states are currently covering and the new 133% of poverty threshold. This amount is gradually reduced over time, reaching 90% by 2020, where it is slated to remain indefinitely. While Medicaid is currently jointly financed by the federal and state governments, this new arrangement has the feds picking up the bulk of the costs of the new coverage. The thing is, some states, like Massachusetts, are already providing coverage of parents up to 133% of poverty. These states that are already quite generous will not receive much in the way of new federal money. By contrast, other states, like Texas, only provide coverage for parents up to 26% of poverty (that’s less than $3,000 a year). When they opt-in to the Medicaid expansion, the federal government will pay the full difference in cost of expanding eligibility up to 138% of poverty. That’s a lot of federal money to states like Texas. Generally, the more conservative states are the ones with the most uninsured persons and the strictest Medicaid eligibility requirements. Therefore, they are also the ones who will gain the most under the ACA.

Of course, this depends on their willingness to participate in the Medicaid expansion, which is optional. The ACA did include a provision that said that if states didn’t participate in the Medicaid expansion, the federal government could also withdraw their funding for the existing Medicaid program. The Supreme Court, however, said that this was coercive and unconstitutional. The result is that states are free to participate in the program or not, without fear of repercussions. Politically, republican governors are adamant about resisting implementation of the Affordable Care Act. Louisiana’s Bobby Jindal has already proclaimed that his state, whose health statistics place it squarely in the bottom of the country (50th in 2008, rising to 49th by 2011), will not be creating an insurance exchange and will not be participating in the Medicaid expansion. It’s unfortunate, because the people in these states are the ones who desperately need help the most.

Of course, the politically-motivated decision not to play ball will only hurt these states further, as they walk away from literally billions of dollars in federal assistance that would boost their economies and improve the health of their residents. There will also be pressure from organized health care interests to participate, because that money will reduce their uncompensated care costs. So, I’m not sure if the rhetoric we’re hearing today will hold true in the end. If it does, though, it will be a great example of bad politics dominating good policy, and the people it will hurt the most are the ones who are already wounded.

Update: As Nicole points out in the comments, the actual threshold is even higher than I originally stated. Medicaid eligibility goes up to 138% of poverty, not 133% as I had written. I have updated the text to indicate this.

 

The Supreme Court Ruling Is Finally Here

After many months of speculating on the outcome of the Supreme Court’s ruling on the Affordable Care Act, the decision was finally announced today. The ruling essentially upholds the entire Affordable Care Act as constitutional. While this is certainly the outcome that I had been hoping for, I am also convinced that it is the correct one. I haven’t read the dissenting opinions yet, but I’m anxious to see how they justified that. I, for one, am glad to have this piece of the puzzle put in place, because it helps us to move forward with the goal of improving our health care system. Call it the ACA or call it “Obamacare” it is the constitutional law of the land, and there is no appealing that, so perhaps it’s time to get used to it, and figure out how to make it work for you.

That said, while Supreme Court majority and dissenting opinions are not terribly complex, they do have to be read rather carefully to be well understood. Perhaps that explains why CNN made me nauseous with its incorrect headline proclaiming “Breaking News: Supreme Court Strikes Down Individual Mandate” for about 10 minutes before it got the story straight. I just printed out the opinions, all 193 pages of them. I’m not surprised that someone skimming got it wrong in their attempt to be first, but they should have sensed something when they saw Chief Justice Roberts aligning with Justice Ginsburg.

Rather than exercise a similar rush to judgment, I’m planning to spend the weekend reading through everything and formulating my thoughts, which I will post here on Monday. For now, I’m going to go bask in the glow that comes from a conservatively appointed chief justice putting the law before partisan politics. This has renewed my faith in America a little bit.

 
 
%d bloggers like this: