Latest Drugwonks' Blog
"Developers of companion diagnostics products, integral to the advancement of personalized medicine, may receive a much-needed financial boost from Congress covering their research and development expenses if a new bill introduced by Rep. Patrick Kennedy (D-RI) passes.
Not so fast. The credit is offset against any expensing of R&D activities on corporate returns. And the carry forwards on the credits are non-existent as far as I can tell but I am no tax lawyer....
Meanwhile the bill, while well intended, creates new agencies, work groups and layers of review for a personalized diagnostic climb through before it gets approval, thereby adding to costs that can't be claimed under the credit itself.
Are tax credits the only thing pols can come up with to promote innovation?
Why not, for instance, build on the work of the C Path Institute?
"Last October....the C-Path Institute announced that it will use a $2.1 million Arizona state grant to help Ventana take a lung cancer diagnostic through the FDA and standardize a regulatory pathway for companion diagnostics and therapies [see PGx Reporter 10-17-2007].
Johns Hopkins University’s Genetics and Public Policy Center’s Gail Javitt notes: “New committees and layers of bureaucracy are proposed when what is needed are concrete steps to enhance oversight and improve laboratory and test quality. …"
Let's hope clearer minds and the Critical Path prevail...
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Meanwhile the hero of the Far Left -- Hugo Chavez -- provides a preview of how health care will fare under Obama and others in Congress seeking to cut Medicare spending through price controls and rebates:
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Venezuela's oil output slumps under Hugo Chavez
Venezuela's daily oil production has fallen by a quarter since President Hugo Chavez won power, depriving his "Bolivarian Revolution" of much of the benefit of the global boom in oil prices.
To win allies and forge an anti-American front, Mr Chavez sells oil to friendly countries at low prices. Ironically, the only big customer buying Venezuelan oil at the full market price is the United States, which the president routinely denounces as the "Empire".
"As production falls, the sales to the US become more important," said Pietro Donatello, an oil analyst from Latin Petroleum in the capital, Caracas. "Only the US is paying the full amount for Venezuelan oil and in cash, the rest are in some kind of barter agreements."
The state oil company, PDVSA, produced 3.2 million barrels per day in 1998, the year before Mr Chavez won the presidency. After a decade of rising corruption and inefficiency, daily output has now fallen to 2.4 million barrels, according to OPEC figures. About half of this oil is now delivered at a discount to Mr Chavez's friends around Latin America. The 18 nations in his "Petrocaribe" club, founded in 2005, pay Venezuela only 30 per cent of the market price within 90 days, with rest in instalments spread over 25 years.
The other half - 1.2 million barrels per day - goes to America, Venezuela's only genuinely paying customer.
Meanwhile, Mr Chavez has given PDVSA countless new tasks. "The new PDVSA is central to the social battle for the advance of our country," said Rafael Ramirez, the company's president and the minister for petroleum. "We have worked to convert PDVSA into a key element for the social battle."
The company now grows food after Mr Chavez's price controls emptied supermarket shelves of products like milk and eggs. Another branch produces furniture and domestic appliances in an effort to stem the flow of imports. What PDVSA seems unable to do is produce more oil.
Venezuela has proven reserves of 80 billion barrels, but estimates suggest that it may possess 142 billion barrels - more than anywhere else except Saudi Arabia. But the crude is of low quality and must be upgraded before it can be shipped. There are only three upgrade units currently operating, processing only 600,000 barrels per day.
"There is a bottleneck in the Venezuelan production system," said Mazhar al-Sheridah, 68, an oil expert at the Central University of Venezuela. "It will cost at least $32 billion to build another three upgrading units and take some five years, meaning that Venezuelan production is stuck at current levels for a while yet."
All this means that Venezuela has missed much of the benefit from the oil boom and, now that prices are falling, Mr Chavez faces huge financial problems. Nobody is sure at what point his government would be unable to pay its bills, but most sources consulted believe this would probably happen if oil falls to $80 a barrel. Yesterday, oil was trading at $79.80.
If you want to see the future of pharma/academe collaboration, then the current edition of Intensive Care Medicine is a must read. The particular issue is the contentious debate over the role of the Eli Lilly & Co. drug, Xigris (drotrecogon alpha/activated – DAA), in severe sepsis. But there are much larger issues at play.
According to the Financial Times:
“Drug distributors who arbitrage the price differences across the European Union could see their €4bn ($5.5bn) a year trade severely curtailed under proposed legislation set to be unveiled by the European Commission later this month. A document obtained by the FT includes rules to crack down on the trade in counterfeit medicines that would make it difficult for wholesalers legally to move pharmaceuticals across the EU's open borders. New rules would put tight restrictions on the repackaging of medicines, a process required to ensure the correct language and coding information is used on packaging and information leaflets.”
“The repackaging controls, drafted for Günther Verheugen, EU trade and industry commissioner, as part of broader reforms to laws governing the pharmaceutical sector, have been justified as a way to reduce the threat of counterfeit medicines, which the pharmaceutical industry says is a growing danger to patients' health.”
On the other side of the issue, Heinz Kobelt, secretary-general of the European Association of Euro-Pharmaceutical Companies, which represents parallel traders, said the Commission had been unable to provide any evidence that parallel traders had allowed counterfeit prescription medicines to enter the pharmacy chain.
Heinz has a very selective memory.
Earlier this year, at a
Oops.
* Eighty-three percent of millennials believe that America’s health care system is in need of reform and that health care insurance should be available to all Americans; and,
* Seven in ten millennials support the creation of a new government program to manage and administer public health insurance coverage options, and 6 in 10 were okay with increasing government spending to support health care reforms.
However, as the potential cost of health care reform was shifted directly onto individuals and not the government the level of support for reform ideas also shifted among millennial voters.
* A majority (51 percent) were not in support of any health care reforms thatcould raise their personal tax burden;
* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,
* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.
This healthcare “idealism gap” among millennial voters speaks to a large divide between what this group is hearing from politicians and pundits -- and what they are willing to accept. This insight into how younger voters think and feel about these healthcare reform shows that all sides of the debate need to do a better job educating this important voting bloc about how various reform plans will impact the future of medicine in
For further details please go to www.biggovhealth.org.
This poll is the result of 1001completed interviews with adults 18-28 years of age who are registered to vote. Respondents were selected at random from the 48 contiguous states. The interviews were conducted between September 12th, 2008 and September 20th, 2008. The margin of error for this study is ± 3.09 percentage points at the 95% confidence level. Interviews were monitored at random.
Then he keeps on claiming he can reduce premiums by $2500. An exaggeration that is on the verge of a lie... Half of that is supposed to come from costs generated fromo electronic health records! But his estimate of "savings" from EHRs is based on productivity gains which themselves are estimates drawn from private sector examples in the auto industry over ten years. The other amount comes from "disease managment" savings achieved by getting doctors to practice guideline driven medicine. That's called rationing. Also unlikely. And even David Cutler, one of the smartest health care analysts in America acknowledges that the $2500 doesn't translate into reduce premiums:
Obama health adviser Cutler confirmed that the campaign's $2,500 per family projection doesn't represent only out-of-pocket savings for individual Americans. It includes savings to the government, employers and insurers, savings that could, Cutler says, trickle down to families in the form of lower taxes, higher wages or reduced premiums. In fact, Cutler says the $2,500 figure simply comes from dividing an overall savings estimate that's somewhat larger than $120 billion by an approximate number of four-person families in the U.S. "[W]e take the total and divide by the total population, then consider a 4 person family,"
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Barack Obama:
“I happen to be a proponent of a single payer universal health care program.” (applause) “I see no reason why the United States of America, the wealthiest country in the history of the world, spending 14 percent of its Gross National Product on health care cannot provide basic health insurance to everybody. And that’s what Jim is talking about when he says everybody in, nobody out. A single payer health care plan, a universal health care plan. And that’s what I’d like to see. But as all of you know, we may not get there immediately. Because first we have to take back the White House, we have to take back the Senate, and we have to take back the House.”
Barack Obama on single payer in 2003
Guess what
Mammograms: 88.6% of American females 40-69 had ever had a mammogram compared to 72.3% of Canadians.
Women are ten percent less likely to survive five years with a breast cancer diagnosis in Canada and 20 percent more likely to die from breast cancer in Canada. If rates were adjusted for race and stage the difference would likely be higher.
Though the breast cancer drug Herceptin was approved in 1998 it was first used in Canada in 2005 and even then it's access to high responders was rationed.
Read more here
Change we -- and women with breast cancer -- don't need.
So does hopeful money -- since October is Breast Cancer Awareness Month.
That being the case, which candidate deserves to wear the Pink Ribbon?
A few questions to consider before answering:
Which candidate supports a platform that would accelerate the pharmaceutical community and the FDA down the Critical Path?
Which candidate supports a program that believes in getting women with breast cancer the most appropriate care as early in their disease state as possible?
Which candidate supports a program that understands the value of incremental innovation and the "price/value" equation?
Will either candidate speak up for "the four rights" -- the right medicine for the right patient in the right dose at the right time?
Will either candidate wear a pink ribbon tonight?
Will either candidate wear a pink ribbon for reasons other than optics?
Barak Obama's campaign released a horribly misleading ad about McCain's health care proposals, claiming that it would lead to millions losing health care coverage, raise taxes and hand over cash to insurance companies.
The claims have failed every fact-check – from CBS[1] to the Washington Post.[2] John McCain is not going to raise taxes on middle class families....
Transforming The Tax Code To Create Greater Equity: The McCain plan transforms the current tax code to provide all American families – including the self-employed and the uninsured – the same tax benefit, a $5,000 refundable tax credit ($2,500 for individuals) that was previously only available to those with employer coverage. Families can use this credit to purchase insurance of their choice, including keeping their current coverage. This is an approach supported by Barack Obama's own Senior Economic Advisor Jason Furman who wrote that "we could scrap the current deduction altogether and replace it with progressive tax credits that, together with other changes, would ensure that every American has affordable health insurance."[3]
· Better Than "Members of Congress": Under the McCain Plan, your employer can provide you with health insurance as good as a "Member of Congress", and you would pay no more in taxes – regardless of your tax bracket. In fact, you would have some additional money left over from the McCain tax credit to put in a health savings account.
· On The Issue Of the Congressional Plan – There Are Options, But All Are Under The FEHB Program: A good example is the Blue Cross and Blue Shield Service Benefit Plan, which has combined monthly premiums for family coverage of $1027.95, for an annual cost of $12,335.40.
| Income Tax Liability | McCain Tax Credit | TOTAL Tax Savings |
10% Bracket (Up to $15,650) | $1,200 ($12,000 x 10%) | $5,000 | +$3,800 |
15% Bracket ($15,650 -63,700) | $1,800 ($12,000 x 15%) | $5,000 | +$3,200 |
25% Bracket ($63,700-128,500) | $3,000 ($12,000 x 25%) | $5,000 | +$2,000 |
28% Bracket ($128,500-195,850) | $3,360 ($12,000 x 28%) | $5,000 | +$1,640 |
33% Bracket ($195,850 -349,700) | $3,960 ($12,000 x 33%) | $5,000 | +$1,040 |
35% Bracket (349,700 and over) | $4,200 ($12,000 x 35%) | $5,000 | +$800 |
· Where Is The Middle-Class "Tax Increase"? If you or your family is in the 28% bracket, with an income of $180,000, you could receive employer provided health insurance even better than a Member of Congress, with a cost of almost $18,000, with no increase in taxes. Even the liberal leaning Tax Policy Center, agrees that the McCain proposals will result in a "net tax benefit" of more than $1,200 for an average tax payer.[4]
· Helping Those Without Employer Coverage: If you are a middle-class American today without employer provided health care, the McCain plan would give you a tax credit of $2,500 as an individual, or $5,000 for a family, to help you buy your own health insurance coverage, including across state lines. American families – not government bureaucrats or insurance companies – will choose the coverage that best meets their needs. Today, the government does nothing to help you. Why does Barack Obama oppose this?
· McCain Health Plan Puts Families in Charge: In another desperate attack, Barack Obama and Joe Biden have said that McCain health care tax credits to help families buy coverage "will go straight to the insurance company." Here is what they fail to mention – the credit goes to the insurance company that the American family chooses to get coverage from, anywhere in the nation. The power of choice lies with the family – not government bureaucrats or insurance companies. Ridiculing this line of strange attack, The Associated Press stated, "Of course it would, because it's meant to pay for insurance. That's like saying money for a car loan will go straight to the car dealer."[5] Furthermore, any additional money left over after purchasing coverage will be controlled by the family in a portable health savings account.
· McCain Health Care Plan Protects Our Vulnerable Population: John McCain believes that no American should be denied access to quality and affordable coverage simply because of a pre-existing condition. As President, John McCain will work with governors to develop a best practice model that states can follow – a Guaranteed Access Plan or GAP – that would reflect the best experience of the states to ensure these patients have access to health coverage.[6] There would be reasonable limits on premiums, and assistance would be available for Americans below a certain income level.[7]
· McCain Health Care Plan Gives American Families More Choices: John McCain believes that American families should be given more choices by allowing them to purchase policies across state lines. In a move derided by fact checking organizations including Fact Check, the Obama campaign used this as an opportunity to falsely accuse John McCain of deregulating health care markets akin to Wall Street.[8] A recent study showed that simply allowing Americans to purchase across state lines would reduce the number of uninsured by almost 12 million.
· McCain Health Care Plan Preserves Employer Coverage: The McCain health plan builds on the employer-based system. Employers will have the same incentive to provide health insurance as they do today since they will continue to deduct the cost of health insurance they provide to employees. Nothing will change. In addition, payroll taxes will be protected from taxes under the McCain plan. Millions of American families with employer sponsored coverage in all tax brackets with the same coverage as a "Members of Congress" will now come out ahead with additional funds going into a portable health savings account. Importantly, younger and healthier employees with the McCain health care tax credit will have a bigger incentive to stay with the employers. For example, a 25-year-old employee in the 25 percent tax bracket with a $2,500 tax credit could either purchase a policy in the individual market for the same amount or stay with his employer plan and receive a $5,000 policy with an additional $1,250 to invest in a portable health savings account. Why would people choose worse insurance and less money? Finally, the McCain plan through comprehensive cost-containment policies addresses the single biggest threat to employer coverage – rising costs.
The truth about Senator Obama's health plan:
· Barack Obama's Plan Continues The Push Toward Government-Run Healthcare: The Obama plan will create a brand new government-run health plan at the cost of $243 billion a year – a financial burden of more than $3,000 a year on American families.[9]
· Barack Obama's Plan Will Harm Employer Coverage: The Obama plan includes a $179 billion a year employer mandate.[10] The mandate requires employers to either provide "meaningful" coverage or pay a tax towards the government plan.[11] Faced with tough economic conditions and rising health costs this creates a clear incentive for employers to drop coverage and move families into the new government plan. A Lewin Group study which examined a similar employer mandate combined with a national plan, like the Obama plan, concluded that almost 52 million individuals would lose their private employer coverage.[12] To maintain their competitive edge, others employers will follow - spelling the demise of the employer coverage system.
· Barack Obama's Plan Will Damage Private Coverage: The government-run plan will have a clear advantage over private insurance since it will be subsidized by American taxpayers. A recent analysis of both plans by the nonpartisan CATO Institute concluded that the Obama government-run plan will be able to "keep its premiums artificially low…since it can turn to the U.S. Treasury to cover any shortfalls" resulting in "undercutting the private market."[13] According to Wall Street Journal, the goal of the Obama plan "…like HillaryCare in the 1990s, is to displace current private coverage and switch people to the default government option."[14]
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.
