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A majority of the Court, in an opinion written by Justice John Paul Stevens, sided with Ms. Levine. But the ruling is difficult to square with the Riegel decision last term, where a 7-2 majority held that FDA approval shields medical devices from most lawsuits. Moreover, it's unclear that a stronger warning would have mattered.
The drug's label clearly stated that the "IV push" method employed to deliver the drug to Ms. Levine should be used as a last resort and that "INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY." As Justice Samuel Alito explains in his dissent, "the physician assistant who treated [Ms. Levine] disregarded at least six separate warnings that are already on Phenergan's labeling, so [Ms. Levine] would be hard pressed to prove that a seventh would have made a difference."
But Justice Alito's larger point is that "drug labeling by jury verdict" undermines the workability of the federal drug-labeling regime. Juries are presented with tragic plaintiffs who were injured, not the unknown patients who are helped, by a product. Hence, they tend to focus on risks more than overall benefits. By contrast, federal regulators are tasked to take the long view and factor in the interests of all potential users of a drug. Just as importantly, "the FDA conveys its warning with one voice," writes Justice Alito, "rather than whipsawing the medical community with 50 (or more) potentially conflicting ones."
Read More & Comment...“Such women must wait up to five years until their condition worsens by up to 60 per cent before they are allowed alternative medication, such as the drug strontium ranelate.”
Read More & Comment...
Yesterday I debated Peter Lurie (Deputy Director of Public Citizen’s Health Research Group) at The First Annual Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies (keynote speaker was Senator Charles Grassley). Our session was billed as a “cage match.” We agreed on many points – and disagreed – very strongly – on others.
Here’s what I had to say:
Four months ago the New York Times reported that:
“The Journal of the American Medical Association cited “concerns about misleading reporting of industry-sponsored research” to justify its stricter standards for any such research to be considered for publication. The new policy, requiring researchers with no financial connections to the sponsor to vouch for the data and perform statistical work, was promptly criticized in an editorial in The British Medical Journal as “manifestly unfair” because it created a “a hierarchy of purity among authors.”
Considering that JAMA accepts advertising from the pharmaceutical industry and openly promotes the sales and marketing of reprinted articles – the concept of a “hierarchy of purity” is a nice turn of a phrase. It sounds better than “hypocrisy.”
Facts are an even better indicator. Consider an analysis published in The International Journal of Obesity and financed not by industry but by the National Institutes of Health. After analyzing weight-loss research conducted over four decades, they’ve found that the quality of data reporting in industry-sponsored research does indeed seem to be different from that in other research: It’s better.
The researchers found that the quality of data was significantly better in industry-supported research than in nonindustry-supported research, particularly in studies involving drug treatments. The researchers conclude:
According to the New York Times, “This suggests that, while continued efforts to improve reporting quality are warranted, such efforts should be directed at nonindustry-funded research at least as much as at industry-funded research.”
So, all of the righteous indignation about “bad” industry tainting “good” researchers is mostly hyperbole. But it makes for great copy.
When it comes to the future of medicine and the treatment of patients, we all need to move beyond one-dimensional attitudes – despite the fact that it makes for great speeches on CSPAN and headlines for “investigative” journalists.
New York Times reporter Gina Kolata recently reported that some prominent medical researchers are starting to shun any financial support from industry — not because they think it leads to bad research but because they’re tired of having their integrity impugned. By stigmatizing industry-sponsored research, is the “hierarchy of purity” doing more harm than good?
Is there an unintended negative consequence of transparency? Yes, when it is usurped by those who would put politics ahead of the public health.
A recent editorial on Nature Biotechnology put it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”
Transparency is important. It is urgently important. Transparency permits trust. Sunshine is the best disinfectant – but what’s good for the goose must also be good for the gander.
But let’s be honest. The Sunshine Act with all of its high-minded language about transparency is really just about slamming the pharmaceutical industry.
That’s politics trumping the public health.
Why isn’t anyone concerned about the payments physicians get from insurance companies to switch patients from brand name to generic medicines, or from trial lawyers to be expert witnesses?
If physicians and academicians are paid by industry for their medical expertise – and those payments are important to disclose – why aren’t payments for that same expertise important to disclose when they’re being used by insurance companies and lawyers?
When is a conflict not a conflict? The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
Who’s pure and who isn’t? Here’s the answer – nobody is 100% pure. Not even Ivory Soap is 100% pure – and it floats! And politicians are certainly not 100% pure. Not even ones from
In the February 7th edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
His main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism." It's what's in the best interest of the patient.
- Health care costs are out of control
- Coverage is unaffordable
- We need to invest in quality and prevention and provide incentives for both
- Health IT will allow us to deliver better care at a lower cost
- We need to increase access and increase spending on prevention (but all of the above cost money)
Is there enough overutlization to pay for underutilization?
Are there enough smart people in that room to decide what is overutilized and underutilized?
Hardly.
Read More & Comment...
Drug Imports May Become Legal in U.S. Under Obama, McCain Plans
By Tom Randall
March 4 (Bloomberg) -- Americans may soon be able to buy cheap drugs imported from other countries without fear of breaking the law, now that a five-year push in Congress for new rules has gained support in President Barack Obama’s budget.
A proposal to allow drug imports was introduced today by Senator John McCain, an Arizona Republican defeated by Obama for the presidency, along with Democratic Senator Byron Dorgan, of North Dakota, and Republican Senator Olympia Snowe, of Maine. Obama called for the changes in his budget last week, and views the measure as one way to reduce health-care costs so that medical coverage for the uninsured can be expanded.
Brand-name drugs in other countries cost as much as 70 percent less than in the U.S. Allowing imports would save Americans $50 billion over the next decade, including $10 billion for the U.S. government, the lawmakers said. Dorgan and Snowe previously introduced similar legislation opposed by the pharmaceutical industry and former President George W. Bush.
$50 billion? That's based on all consumers paying retail prices at the drugstore and presumes a significant increase in the amount of consumption of imported drugs paid at the difference in retail prices...
Sorry but the reality is that every drug importation program at the state level has been a failure. Meanwhile the threats to the safety of medicines have grown.
Randall claims that a " 30-pill prescription of 20- milligram doses ( Lipitor) costs $124.99 at the U.S. site, compared with $60.78 from Canada.
Not exactly. The internet sites CLAIM they are Canadian but the drugs from such countries as Turkey and Singapore. Meanwhile HealthCanada will not guarantee the safety of medicines brought through Canada and resold into the states.
Meanwhile, the legislation would force companies to sell their drugs to foreign wholesalers at the government set price in any amount they want. Imagine if McCain or someone else introduced legislation forcing car companies to re-import cars made in China at the Chinese market price.
http://www.bloomberg.com/apps/news?pid=20601103&sid=abzWU.GPNrjc&refer=us
(1) People can sue drug companies for risks that are already on the drug label.
(2) But companies cannot unilaterally change the label when new information arises.
(3) And patients can also sue innovator companies for adverse events caused by generic versions of their molecules produced by other companies.
(4) And somehow this isn't going to impact either innovation or cost.
(5) The current majority party wants to restrict drug marketing through increased FDA regulatory authority.
(6) Yet they defenestrate the agency's ability to enhance safety by denuding ... the drug label.
(7) And politicians want the FDA to guarantee the safety of drugs from a gaggle of nations.
(8) But the FDA label doesn't count within our own borders.
(9) So now people can sue innovator companies for adverse events from medicines imported from foreign countries.
(10) One wonders about medicines that are compulsory licensed in places like Thailand (and manufactured in India).
(11) Can people sue when these drugs go bad as well?
Is it just me, or does it seem that the government wants to regulate everything except for what benefits the tort bar?
Read More & Comment...
So would the Dartmouth gang and everyone drinking their claims driven kool-aid agree that minorities are suffering from "overuse" of care? Should we reduce the number of screenings, hospitalizations, interventions? Should we not eliminate the disparity that exists in the quality of cancer care and just keep minorities on the older chemo drugs with more toxic side effects because they are "just as effective" or do not improve "overall survival."
In general, where is the hard evidence that the amount of overuse by episodes of treatment linked to severity adjusted outcomes data is greater than the amount of underuse of what is appropriate for subpopulations?
We don't know. But the debate is being cut off in a rush to confirm assumptions that validate a political goal.
Ultimately, such an approach and the sloppy research to support it will deepen the racial divide in health as more and more government financed healthcare is doled out according to "least expensive" practice and restrictions.
There will be a lot babble at tomorrow's White House healthcare summit, happy talk from those giddy over having a "seat at the table," My guess is no one will question whether the comparative effectiveness is tantamount to Jim Crow medicine...
Read More & Comment...
WASHINGTON (AP) — The Supreme Court has upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea that it limit lawsuits against drug makers.
In a 6-3 decision Wednesday, the court rejected Wyeth Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.
The decision is the second this term that rejected business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.
More to follow.
Why did the Government of India oppose the 'counterfeit drug' definition proposed by IMPACT?
Spicy IP
By October the ET reported that the Indian Government had rejected the definition being proposed by IMPACT because it was concerned that the definition could be used to hinder the export of the genuine generic drugs from India. The DGCI was quoted, by the ET, as saying “The government is concerned about certain words being used in the new definition of counterfeits proposed by IMPACT. We are afraid developed countries may use such a definition to stifle the growth of our generic industry”. Civil society groups shared the Government's apprehensions since according to them the new definition would hamper the access to generic drugs.
By January the newspapers were reporting that the Indian Government scored a major victory at WHO meeting on counterfeit drugs because WHO had decided to shelf the new definition in face of opposition from developing countries spearheaded by India & Brazil. Ideally a debate on the definition of counterfeit drugs should have had public health concerns as its central focus. Interestingly the powers that are to be have articulated this debate in the language of trade barriers & survivability of export based generic drug industries. Even more interesting are the tactics used to influence this debate. Forget the definition, the very credibility of IMPACT as policy making institution itself was questioned by its critics. Allegedly the funding of IMPACT is under scrutiny since it is suspected that 8% of its funding is received from the 'industry' and it is also speculated that IMPACT's high degree of co-ordination with big pharma companies may actually be causing a conflict of interest. The text of one of WHO's resolutions makes a clear mention that 62% of IMPACT's funding comes from the EU, while another 30% of the funding comes from WHO. Oddly its silent on the remaining 8% funding. Personally I don't think the question of funding is such a big deal. As long as logic and reasoning are apparent in the definition it is irrelevant who paid for it. Allegations of irregularities in funding simply distract the focus from the main questions. If there is a problem with the definition it is possible to attack it with reason and logic. Another reason behind the allegations of conflict interest is the fact that IMPACT's chair on technology – Dr. Harvery Bale is also the Director General of the International Federation of Pharmaceutical Manufacturers & Association (IFPMA). Indian company Piramal, Ranbaxy's new owners Daiychi Sankyo & India based OPPI are all members of IFPMA which represents mainly innovator companies, all of whom are affected by counterfeit drugs. It is ridiculous to suggest that no member of IFPMA should have been involved with IMPACT. After all counterfeiting is as much their problem as the rest of the world’s and they are probably the most experienced.
Anyway enough of the conspiracy theories. It’s time to deal with the main issues. What is IMPACT? What were the issues it sought to discuss? & Why is its definition of counterfeit drugs so controversial?
What is IMPACT?
Back in 1999 a WHO report had warned that counterfeit drugs were posing an increasingly serious public health crisis. One of the most serious problems was that there was almost no global study as to the true magnitude of the problem. In 2006 the participants of theWHO International Conference on Counterfeit Drugs passed a resolution (The “Rome Resolution”) to initiate policy measures to co-ordinate action against counterfeit drugs on an international scale. One of the proposals of this resolution was to setup a dedicated body – IMPACT – consisting of governmental, non-governmental and international institutions to raise awareness about the counterfeiting menace and increase co-ordination and information sharing amongst different countries. For its part IMPACT defines itself as “a partnership comprised of all the major anti-counterfeiting players, including: international organizations, non-governmental organizations, enforcement agencies, pharmaceutical manufacturers associations and drug and regulatory authorities.” You can click over here to access IMPACT's website.
What was the definition that IMPACT proposed?
In pursuance to WHO Resolution No: WHA 41.16, an international conference on counterfeit drugs was held in 1992. The participants of that conference, which included a large number of member countries, Interpol, the World Customs Organizations, the International Organization of Consumer Unions adopted a definition jointly formulated by the World Health Organization (WHO) and IFPMA, which is as follows:
A medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
In December 2008 the Secretariat of the World Health Organization introduced for the first time a new draft of a definition as proposed by IMPACT. The new definition is as follows:
The first limb of the definition, defines a counterfeit drug:
A medical product is counterfeit when there is a false representation1 in relation to its identity2 and/or source3. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components4, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.
The second limb of this definition, defines what is not a counterfeit drug:
Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices in legitimate and medical products should not be confused with counterfeiting.
In addition, the first limb of the definition has four footnotes as shown above and expanded below:
1- Counterfeiting is done fraudulently and deliberately. The criminal intent and/or careless behaviour shall be considered during the legal procedures for the purposes of sanctions imposed.
2- This includes any misleading statement with respect to name, composition, strength or other elements.
3- This includes any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorization holder or steps of distribution.
4- This refers to all components of a medical product.
(NOTE: There have also been some references to the use of the word 'history' along with 'identity' and 'source' but I have not been able to find a mention of that in any of the WHO resolutions and hence have not discussed it. Please do let me know if any of you find a mention of it anyway.)
What is so new in the new definition of a “counterfeit drug”?
1- The new definition uses the word ‘medical product’ instead of ‘medicine’. Some news reports have tried to point out that this is problematic because the initial WHA resolutions refer to only medicines. This however is not logical because a counterfeit condom can prove to be as dangerous, if not more, as a counterfeit drug.
2- Apart from that the new definition replaces the words ‘deliberately and fraudulently mislabelled’ with the words ‘false misrepresentation’. The new definition however also inserts a footnote after ‘false misrepresentation’ stating that “Counterfeiting is done fraudulently and deliberately. The criminal intent and/or careless behaviour shall be considered during the legal procedures for the purposes of sanctions imposed”. I'll deal with this in more detail later.
3- The third change in the new definition is this next sentence: “This applies to the product, its container or other packaging or labelling information.”
Apparently points 2& 3 turned out to be the most controversial part for the Indian government and generics. I’ll deal with this below.
The second limb of the definition: How the definition actually addressed the concerns of developing countries
1- A senior government official was quoted in this news report as saying “Calling trademark violations counterfeit may also mean that if a drug is not registered in a country then it becomes a counterfeit, which is completely wrong. The drug may not be registered because it may not suit that country’s environment. This does not make it a counterfeit.” Clearly these objections seem to have been taken into count because the final draft of the definition had this: “Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit.” This, I think, is a major concession for as EU backed (as alleged) committee to make especially given the weak regulatory architecture in some of the developing countries.
2- There have been some news items such as this one which (way back in May, 2008 before the final draft was ready) speculated that the new definition may club 'sub-standard' medicines with 'counterfeit' medicines. This view was echoed in several other reports. However the IMPACT definition puts to rest this apprehension. The new definition clarifies that “Substandard batches or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices in legitimate and medical products should not be confused with counterfeiting.” This distinction has been criticised by many since it is widely thought that sub-standard drugs pose as much a problem as counterfeit drugs. Read one such critique here. In fact an expert committee constituted by the Government of India some years ago dealt with the problem of spurious/counterfeit drugs in the same breath because it reasoned that both were equally dangerous. Sub-standard drugs may in fact be even more dangerous because they may cause higher resistance levels to be triggered amongst some pathogens. In all probability IMPACT wanted to focus exclusively on counterfeiting issues without any distractions.
3- Some of you may have been following our recent posts on the secretive negotiations over the ACTA. One of the proposals of the ACTA was to classify all patent-infringing drugs as counterfeit. That is a dangerous proposal because while most patent statutes do not prescribe a criminal punishment for patent infringement almost every anti-counterfeiting statute will result in a jail term. Additionally, the EC when publishing its annual anti-counterfeiting reports was classifying even patent infringing goods as counterfeit as a result of which Switzerland accounted for 39.21% of all counterfeit drugs entering the E.U. The European Generic Association (EGA) which was involved in the IMPACT discussions came out with a brief paper stating its objections to the ACTA's proposal. (This paper can be accessed here). It looks like the EGA managed to impact the final draft because IMPACT's definition clearly states that “Violations or disputes concerning patents must not be confused with counterfeiting of medical products.” Imagine the victory that the developing countries could have ensured themselves if they had decided to adopt the IMPACT definition. Instead they have clearly stated their opposition to this definition thereby keeping the door wide open for the ACTA proposal.
It is therefore quite obvious that IMPACT was listening to everybody unlike some sources which seem to hint at a biased streak within IMPACT.
What exactly was the biggest objection to IMPACT's definition?
The biggest objection to the new definition as has been reported in news report after news report after newsreport after newsreport (this report by Sriram Iyer was extremely balanced and objective) is the possibility that the new definition would cover even trademark violations i.e. even drugs with correct ingredients but violative trademarks will be classified as counterfeit drugs. As put in one news report “This had spread fear amongst the Indian industry that if deviations were found in packaging, container and labelling, their drugs would also be deemed counterfeit even if they contained the right chemical ingredient.” The fear thus was that developed countries would use this definition as a tool to hinder the export of generic medicines from countries like India. The Indian Pharmaceutical Alliance, the SME Pharma Industries Confederation (SPIC) and several other generic drug manufacturers associations along with several NGOs have opposed the new definition because they fear that the definition will deem even trademark violations to be counterfeits. According to the critics of the definition the fact that the new definition replaces ‘deliberately and fraudulently mislabelled’ with the words ‘false misrepresentation’ apart from inserting a new line - “This applies to the product, its container or other packaging or labelling information” greatly increases the possibility of trademark violations leading to drugs being deemed counterfeit. In addition 'identity' is interpreted to mean “misleading statement with respect to name, composition, strength or other elements.” In the words of one critic “in the new definition, false representation of identity and source applies not only to labelling but also to the "product, its container or other packaging"; thus false representation with regard to any of those elements would make the product a "counterfeit" within the scope of the definition.
This means that a product also may be classified as counterfeit for example when the shape or color schemes of a product is similar to the competing product irrespective correct labeling information and contents. This is particularly problematic since presently the scope of trademark protection covers not only traditional trademark like words, signs or combination of both but also non-traditional trademark taste, shape, color, touch and feel, smell, etc. Thus, in this case the definition is more about protection of IP elements.”
The above are basically the reasons for opposition to IMPACT's definition. In my opinion this is a wrong interpretation of the definition. However before proceeding any further it is first necessary to take a look at the relevant provisions in the Drugs & Cosmetic Act.
Section 17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be misbranded,—
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of betapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
Section 17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug ; or
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product.
The highlighted portions of the above two provisions of law [Sec. 17(c) & Sec. 17B(e)] are very similar to the amendments proposed by IMPACT. If the new IMPACT definition can classify trademark violations as counterfeit drugs then so can the above two provisions. Both definitions use the word 'false' and 'misleading' in respect of the label or container. Additionally the S. 17 definition uses the words 'design' which is much more specific than the IMPACT definition. The language of Sec. 17B(e) could easily classify all drugs with trademark violations as 'spurious drugs'. Manufacturing or selling mis-branded or spurious drugs are criminal offences carrying prison terms for 3 years and 5 years respectively. There was a proposal a couple of years to amend the 5 year limit for spurious drugs and replace it with either the death sentence or life imprisonment.
The question therefore is why is the Indian Government objecting to IMPACT's definition when the amendments bear so many startling similarities with the definition found in our law? Is it because the Government of India does not implement its own laws or is it just a terrible case of mass hysteria? Everytime an intellectual property issue is brought up by an international organization in the context of public health we presume that there is an 'imperialist/blood thirsty East India type corporation' conspiring against India. The level of paronia is simply unbelievable. It is time India started acting like a responsible, confident nation before it decides to torpedo international negotiations. We could have used this opportunity to clarify certain points with the developing world before the USTR tries to spring any surprises through the ACTA. It would also be nice if the Government could start articulating its concerns in the language of public health and not in the language of the generic drug industry.
What is the actual impact of IMPACT's definition – should it exclude references to trademark law?
To begin with I dis-agree with the presumption that principles of trademark law should not be imported into the definition of counterfeit. The principle aim of trademark law is to prevent confusion amongst consumers since it effects consumers. Principles like dilution entered trademark jurisprudence at a much later stage. When trademark law provides us with a well developed, time-tested, sophisticated jurisprudence it makes sense to borrow from trademark law instead of attempting to create an entire new branch of law. In fact I think we would be hard-pressed to find a more appropriate law to fight this menace of counterfeit drug. Lets now try to understand how this new definition would work.
Contrary to several media reports the new definition does not delete the terms “fraudulent and deliberate” when it inserts the term “false representation”. It only shifts “fraudulent and deliberate” to the footnote stating that “criminal intent shall be considered during the legal procedures for the purpose of sanctions.” At first glance it may seem that the main definition is conflicting with the footnote. The impact of inserting the words 'false representation' is that it probably lowers the threshold to seize counterfeit drugs. Could this pose a barrier to legitimate trade. In all probability it will not. Once the drugs are seized the normal judicial procedures will kick in to determine whether the seizure was valid and whether the drugs were indeed counterfeit.
In my limited understanding, all that the new definition does is that it reverses the burden of proof i.e. any drug making any false representation or misrepresenting any information so as to mislead the consumer will be deemed to be counterfeit and the person manufacturing the drug will be deemed to be guilty until he can prove otherwise. The 'reversal of burden of proof' is not an uncommon proposition in Indian law. Although a majority of our criminal laws are based on the presumption of innocence there are a few special legislations like the anti-narcotic laws, dowry harrasment laws where it is presumed that the person is guilty until he can prove otherwise. The suspect therefore has to either prove that the counterfeit drug is not counterfeit or that they were not in his possession. Although such laws may seem unreasonable such low thresholds for determining guilt are usually a reflection of society's intolerance for particular criminal offences. It is however a moot point as to whether such an approach actually creates a greater deterrent against any possible violation of the law.
In case it is determined that the label, packaging is indeed confusing the quantum of punishment will most probably depend on whether the conclusion was reached on a question of fact, law or a mixed question of law and fact.
In conclusion I think India lost an important opportunity to clarify certain important definitions. As correctly noted by Sriram Iyer of Money Control we've only opened the door for greater uncertainity in the future. For those of you who have actually read till the end, my humble apologies for the length of this post.
What starts out as an interesting article about the role physicians and patients play in healthcare reform also turns up a troubling issue: GroupThink.
Oops.
Here’s what Michael Weber, MD -- one of the original ALLHAT investigators (and Chairman of the Center for Medicine in the Public Interest) recently said:
“Using ALLHAT as an example of an “evidence gap” could be misleading, for the issue is not the information produced by ALLHAT, but rather how it’s interpreted and used.
Admittedly, diuretics are cheap to acquire, though not necessarily cheap to use. Because they cause unwanted changes in such factors as potassium, glucose (which can lead to diabetes) and uric acid (which can lead to gout), the additional costs of extra laboratory tests, follow-up doctor visits and corrective therapies must be reckoned in.
In fact, the British National Health Service, which is guided in drug selections by its highly cost-sensitive National Institute of Clinical Excellence, favors amlodipine (one of the diuretic’s competitors in ALLHAT) as the usual starting therapy for hypertension. This recommendation is based on the
Another powerful study, ACCOMPLISH, was recently presented at the scientific sessions of the
So the claim of an evidence gap is not based on a disregard of evidence, but in fact demonstrates that the opposite is true. Clinicians apparently are aware of the full spectrum of evidence, not just selected portions promoted by a government agency. From the perspective of patients with hypertension, this surely is good news.”
Reporters need to be careful about the claims they make – just like drug companies.
The emphasis on more NIH funding is so typical and so politically self-indulgent I am wondering if just writing blank checks with specific supplicants names identified would be a more transparent way to reflect the pandering involved. The call for a NIH biomarker effort is a guarantee for federally funded sloth. We need a private sector rush to commercialize gene-tests to predict onset of AD and response to medicines instead. And for the call for more comparative effectiveness research on "what works" in treating patients, gee, what an original idea. I wonder who will set that agenda?
Most depressing is the complete absence of any analysis or speaking truth to power about how investment for Alzheimer's product development will not materialize if the Critical Path is not funded, if price controls are imposed, if rebates on the very drugs that benefit seniors in nursing homes are raised across the board, if patent terms for new medicines are weakened, if the biomarkers used to advance survival and quality of life in HIV, cancer and other illnesses are attacked as simply unscientific and companies and the biotech companies that are burning more cash at lower valuations are required not only to conduct longer and more expensive clinical trials to demonstrate survival but produce evidence of comparative effectiveness to the satisfaction of HMOs. And what about the attack on companies that want to support academic researchers and provide funding for CME to disseminate best practices to the primary care docs who provide most of the care for seniors with Alzheimer's.
Newt used to be a provocative and thunderous souce of change in health care.
Unless and until those associated with the NASP stand up for unshackling the private sector, they will be bystanders as well, despite their hard work and good intentions.
I'm sorry. I wish I could be more politic and polite.
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In a background briefing, an official with the White House Office of Management and Budget explained the funding will "begin to lay the basis for safe and effective reimportation at FDA. But we think we need to put some infrastructure and build some processes there to do that."
What’s “reimportation?” If it means bringing back into the US drugs manufactured within our borders and then sent abroad (which is what most people think it means) then there’s no there there.
If, on the other hand, the unnamed official means “importation,” then Katie bar the door on safety, intellectual property rights, and the importation of foreign price controls.
Did President Obama discuss this plan when he met with Canadian Prime Minister Stephen Harper?
Probably not.
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Getting it right with modern drugs
Congress and President Barack Obama should be commended for expressing a strong commitment to modernize the Food and Drug Administration.
The FDA needs funding, resources, and the support of our leaders in Washington if the agency is to get it right in confronting our most urgent health challenges - especially if they want to ensure patients receive the safest, most effective generic medications.
As a top priority, the FDA must move to modernize its standards for approving generic versions of "controlled release" drugs. Controlled release drugs are a new generation of medication. They are engineered to deliver a precise amount of a medicine, at precise intervals, over a period of hours, without losing potency or effectiveness. This controlled release mechanism helps treat patients suffering from some of the most chronic and debilitating conditions - pain, depression, Parkinson's, Alzheimer's or hypertension.
The good news is that more than 20 generic controlled release drug formulations are poised to be released to the market, pending FDA approval. The bad news is that the FDA is using dated generic approval standards to evaluate these modern medications. This is critical considering any deviation from how a controlled release drug is delivered to the body can lead to unbearably painful, harmful or even fatal patient consequences.
For the FDA to approve a generic drug it must, in part, be identical in strength, dosage form, and route of administration to the original, branded drug. But the FDA's tests for controlled release generics are not measuring the very element that makes the original drugs so valuable to patients: the safe, controlled delivery of a specific amount of medication over an extended time. Measurements that don't include time variables simply cannot assure bioequivalence for this class of drugs.
One remedy to the bioequivalence testing shortfall will only require FDA to use multiple time-based measurements of active ingredient concentration. This will allow regulators to compare the complete performance and equivalence of a generic to the original controlled release medication. This is just a small alteration in the testing standards and only requires generic controlled release applicants to submit more data.
Those who would decry this tweak of the measurements miss the bigger picture. Controlled release drugs are only one class in a whole emerging generation of medications - follow-on biologics are another example - that the FDA will need to adapt to and address if it hopes to keep patients safe. There must be no public doubt that all new classes of generic drugs are exactly bioequivalent to branded versions that have been validated by clinical trials and years of use.
By no means is this a call for the FDA to scrap its standards for bioequivalence - not at all. Rather, this is a call to make them more robust and stringent in order to honestly assess a new generation of drugs. Evidence supporting that conclusion is mounting - a host of complaints and reports from patients losing effectiveness after switching from a branded, controlled release anti-depressant to a generic led the FDA to review whether the generic was bioequivalent and therapeutically equivalent to the brand. The review board gave the generic its vote of confidence, but noted its sensitivity to the bioequivalence issue, saying:
"The question is whether the reported lack of efficacy and/or new onset side effects in these patients who switched suggests a problem with the generic product, i.e., lack of bioequivalence to the branded product, or have some other explanation."
Simply put, the generics industry cannot flourish, innovate and compete if it does not inspire the confidence of American patients. For the FDA to continue to ignore the controlled release regulatory oversight is to invite disaster on two fronts: the complete erosion of the generic industry's reputation in the eyes of patients, and, unthinkable, widespread patient harm caused by ineffective controlled release generics.
Many of the health and food incidents over the last few years were hard for the FDA to predict or prevent, given its resources and funding. There will be no excuse, however, if the FDA ignores the potential for harm waiting in this regulatory gap. Pretending there is no risk in changing formulations is not science-based regulation. In the real world, there are no shortcuts to patient safety.
Peter Pitts is president and co-founder of the Center for Medicine in the Public Interest and was a Food and Drug Administration associate commissioner from 2002-04. Robert Goldberg is vice president and co-founder of the Center for Medicine in the Public Interest.
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Uncertainty over new health safety net for jobless
AP – Cassandra Kelsey, 55, of Washington, has a variety of paperwork seen on Thursday, Feb. 26, 2009. Kelsey …
WASHINGTON – The Obama administration rushed to include a health care safety net for laid-off workers in the recently signed stimulus bill, but has not told employers exactly how to make it work.
As a result, tens of thousands of jobless people could wait months before getting help paying for health insurance that their employers previously had covered.
"Too many people are still trying to figure this out," said Heath Weems, director of human resources policy at the National Association of Manufacturers. "There is a lot of confusion."
At issue is the program called COBRA, the acronym for the law that allows workers to keep their company's health insurance plan for 18 months after they leave their job, if they pay the premiums.
The policies are so expensive that only a minority of eligible workers sign up, often those with medical conditions that demand attention. Costs for a family of four can top $1,000 per month."You betcha.
As Peter has noted, divide $700 billion by the real number of the uninsured -- 20 million -- over ten years or better, $70 billion a year by 20 million you get $3500 per person. So why not give people a tax credit and let insurers, health care agents, etc provide a product from scratch that offers insurance coverage that automatically enrolls people, is universal, portable guaranteed issue of some sort, incentives for healthy behavior, a rider that people would pay that would cover out of catatstrophic out of pocket expenses and encourage pre-funding of deductibles via HSAs through employers, direct deposit. etc. Compare that to the unworkable effort to extend COBRA and all it's complexities....and COBRA is so expensive precisely because the health plan it is "replacing" is unfairly subsidized by lower income Americans in favor of health care plans like those that are bankrupting GM and Chrysler.
How to pay for it? End the system that creates the COBRA like plans in the first place and give people a chance to design plans that they truly value with their own money. Encourage more personal responsibility for health. Provide doctors and patients with information on real comparative effectiveness information, information on what health technologies and treatments are best for them, not guidelines twisted by any one interest as Roy Poses of the www.hcrenewal.blogspot.com/ has noted. (Yes, I agree with Roy on this emphatically!) More on this in future post.
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Last night Peter and I were surrounded by people who celebrated Dr. Sol Barer, CEO of Celgene for his leadership and vision in transformational medicine. They and we were graced by the warmth and wit of John Stossel, Rich Bagger, Mike Ferguson, myleoma survivor Elijah Alexander, and Dr. Jules Hirsch -- individuals who are leaders in their respective fields of journalism, the pharmaceutical industry, politics, professional football and academic research. Their charge to us, at the First Annual CMPI Odyssey Dinner, was to dare and endure as they have, on behalf of medical innovation. We were called upon to speak out, to make biomedical innovation a personal and passionate cause -- and to battle against those who vilify its capitalist origins.
I can't thank enough those who gathered with us to begin this new movement -- friends old and new -- for their support, generosity, warmth and participation. Above all, I am left with a memory of your kindness, the appreciation of which I look forward to repaying in the months and years ahead!
Thank you.
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"The Budget supports the Food and Drug Administration’s (FDA’s) new efforts to allow Americans to buy safe and effective drugs from other countries ..."
Don't kid yourself by thinking this has anything to do with lowering costs for seniors (because even the AARP says Part D is a better deal) or "broadening access" for the uninsured (which is what pharmaceutical patient assistance programs are for). Importation is yet another stealth strategy towards a straight up price control regime for medicines. If importation goes forward, you don't need to revoke the Non-Interferene Clause. This has been Rahm Emanuel's strategy for the past few years and now he's an agent in place.
If you like "universal care" provided by Uncle Sam, MD -- you're going to love importation.
Here we go again.
Sing in me, Muse, and through me tell the story
of that man skilled in all ways of contending,
the wanderer, harried for years on end,
after he plundered the stronghold
on the proud height of
So begins Homer's Odyssey. And so began last night's first annual Center for Medicine in the Public Interest Odyssey Award gala dinner.
The dinner (held at the posh Short Hills Hilton) honored Sol Barer, PhD, CEO and Chairman of Celgene, for his lifetime of dedication to the cause of medical innovation. (Watch this space soon for his complete remarks.) Sol is a visionary and the evening was all about him -- but he is all about innovation in the service of patient care.
And while Dr. Barer got the trophy, the hero of the evening was Elijah Alexander, ex-NFL linebacker, husband, father of two -- and survivor of multiple myeloma. (For more on Alexander's fight against multiple myeloma, visit the "Tackle Multiple Myeloma Foundation" website here.)
Elijah talked about his cancer, about the impact it had on his family -- and how innovation saved his life (specifically via Revlimid). He cried. Everyone cried. Even John Stossel, Mr. "Give Me A Break" (and the evening's emcee), misted over.
The evening was all about the importance and urgency of innovation.
Yes -- even innovation via the resurrection of thalidomide.
President Obama says he want to "cure cancer." He should talk with Sol Barer.
But first he should listen to Elijah Alexander.
1. I don't like tax increases. However capping the deductibility of health care expenses at some point does make sense. So does taxing benefits beyond a certain dollar value or income level (inflation adjusted). Obama got that half right.
2. Requiring HMOs to bid using the Medicare actuary's estimate was something President Bush proposed in 2003. Most people don't remember that. Now Obama is proposing the same thing in lieu of the bonus. Will seniors pay more or less? Will they be better off? Hard to predict.
3. No price controls on part D which rewards use of market forces and preventive technologies. Cuts to medical imaging and home health which will likely not stand or will be adjusted.
4. The administration proposes a bundled hospital payment that includes 30 days for post discharge care. Can we say DRG-based capitation? Nothing new here...just another reimbursement code to exploit.
The Obama team did as little as prescriptively possible to come up with $700 billion for universal health care. More -- about a trillion more (at least) will be needed and even then not everyone will be enrolled. And of course enrollment does not equal better health or outcomes. Where will the rest of the money come from? A tax on employers in lieu of providing coverage.
So for the most part the health care reforms are nothing new and the cost is very high. Still, the down payment does little to move us towards "government run" health care. If free market types want to come up with a way to provide people with a choice of health plans that eliminates penalties for pre-existing conditions and a range of insurance products that are affordable that does not involve government control over medical decisions, now is the time. It can't be HSAs alone, which are still a confusing and difficult benefit to provide. It has to protect people from financial catastrophe, reward healthy behavior, reward better outcomes, encourage more personal responsibility. And the proposal has to be bold and big.
Nothing else will compete or do.
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