Latest Drugwonks' Blog
According to the World Health Organization, “Counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities.” And, in an editorial, the editors of the Lancet ask, “So what should be done to tackle the growing problem of counterfeit medicines?”
The Lancet makes a strong and straightforward case for action. “The consequences of counterfeit drugs are diverse, as are the solutions, which lie in collective involvement, responsibility, and responses of all interested parties: health professionals, drug regulatory authorities, judicial entities, and drug companies at both national and international levels. Critical to this effort is strengthening of drug regulatory authorities, which should not only be responsible for improving drug standards, but also provide effective recognition of counterfeit drugs and assist other agencies in stopping their trade. This is especially needed in those countries that have either no drug regulation at all or an impaired or corrupted system. Additionally, enactment and enforcement of new laws for prohibiting counterfeit drugs is vital.”
And the editors ask the obvious and troubling question, “So why is there not yet an international fake drug treaty?”
We all know the answer.
The Lancet tells the often uncomfortable and undiplomatic truth that “the Indian and Brazilian Governments and some non-governmental organisations … believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas.”
As Prashant Reddy opined in Spicy IP, “Every time 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 paranoia is simply unbelievable. It is time India started acting like a responsible, confident nation before it decides to torpedo international negotiations. 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.”
Amen.
It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety.
Working together to raise the regulatory performance of all nations will help all nations create sound foundations to address a multitude of quality and safety dilemmas such the manufacturing of biosimilars, the control of API and excipient quality, pharmacovigilance and, yes, even counterfeiting.
And here’s the sharp tip of the Lancet, “The fight against counterfeit drugs must be strengthened without further delay. It needs consensus among all countries and interested parties, and requires wise and bold leadership from WHO. An indispensable goal of the campaign is ensuring the availability of genuine and affordable essential medicines in developing countries.”
Memo to New Delhi and Brasilia – get with the program … or get out of the way.
According to a report in the Wall Street Journal -- About three years before counterfeit copies of Roche Holding AG's cancer drug Avastin surfaced in the U.S., a case in Syria involved fakes of the same drug, showing the company has been grappling with bootlegging of the product for some time.
In 2009, Syrian authorities seized a haul of phony Avastin at a warehouse there, a Roche document shows. The company confirms the case, and acknowledges it has encountered other "individual cases" of counterfeit Avastin in recent years. Until now, the only other known case of Avastin counterfeits, other than the recent U.S. case, was a 2010 incident in Shanghai.
According to officials in law enforcement and the pharmaceutical industry, at least three smugglers were jailed as a result of hauls in Egypt and Syria in 2009 that netted the fake Avastin and other counterfeits drugs. These people said the trio -- who officials said were part of the same counterfeiting network -- were released from Syrian and Egyptian jails last year.
It's unclear whether the Middle East currently produces fake drugs, acts as a transit corridor, or both. Evidence suggests many counterfeits that transit through the Middle East are produced in China. In the same Syrian raids that netted the fake Avastin in 2009, officials found other fake drugs packaged in Chinese-language bags. Authorities also found Chinese-manufactured equipment that the criminals were using to produce fake drugs.
In the 2010 case of counterfeit Avastin that surfaced in Shanghai, 116 patients were given a fake version of the drug. In addition to being used against cancer, Avastin is prescribed to treat an eye disease that causes blindness. The Chinese patients received injections in the eye, and some suffered complications, according to a report on the incident published last year in the New England Journal of Medicine.
Watch the interview here:
The emphasis on sub-group analysis to establish which patients would benefit most from Qnexa -- with an emphasis on collecting data from everyday patients -- reflects both a shift in the Vivus strategy and a change in FDA's outlook. I think going forward a Steve Nissen will not be able to trash drugs of companies that he doesn't work for to the advantage of products from firms that he does with a sloppy meta-analysis. (As as aside, Nissen's use of a meta-analysis to attack Eric Topol's research on the value of using gene tests to select drugs for stenting procedures was recently laughed off and ridiculed.) And companies that want to move a new product to market would do well to seek approval based on those sub-groups where the benefits exceed the risk. And to be able to monitor disease progression and treatment response after market with simple blood tests would advance approval even more. The more risk can be defined and measured at the subgroup or individual level, the less chance anti-innovation forces will have to block new devices and drugs that have clinical utility.
That's what The Critical Path was supposed to do. It sounds like the Qnexa decision was made consistent with that mission.
http://www.fda.gov/.../Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM292317.pdf
How did counterfeit Avastin enter the American drug supply? One reason is that profiteers masquerading as pharmacists are selling unsafe, unregulated, mislabeled, repacked, and co-mingled drugs to unsuspecting consumers – in Europe. “Over there” the cause of this malaise is known as parallel trade. Here at home we call it by another name -- drug importation. Whatever the moniker, its bad medicine. European parallel trade is the weak link in the western world’s supply chain – and the direct cause of our current misadventures with Avastin.
Last year over 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date.
This means that drugs purchased from a British pharmacy to an unknowing American consumer could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by British pharmacies. In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
Surprised about the path of counterfeit Avastin? You shouldn’t be. There is ample evidence linking parallel importation with the growing threat of counterfeits. In August 2004 counterfeit medicines were found in the legitimate British supply chain after a patient complained of a crumbling tablet. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an immediate alert. Only days later, the MHRA had to issue another alert after a different counterfeit medicine was found in Great Britain’s legitimate supply chain. Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.
Danish parallel trader, CareMed, said it was the link in the journey of fake Avastin from Switzerland to Britain. The fake has been traced back as far as Egypt before entering a complex supply chain that ended in California. (Roche does not make Avastin in Egypt.)
CareMed has admitted to sourcing the drug from fully licensed Swiss distributor Hadicon, and the 167 vials of Avastin 400mg were sold from a transit warehouse in Switzerland directly to a transit warehouse in Britain.
"In fact under our distribution license -- for patient safety reasons -- as a distributor, we are not even entitled to open the packages and check that, for example, batch numbers of the vials correspond to the batch numbers of the packages."
CareMed sold the drugs to a "highly valued and experienced customer" in Britain, which informed it at the end of November that the batch numbers on the vials did not match the packages.
The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.”
Facts are stubborn things.
Just before the end of 2011, the FDA approved an adult indication for Prevnar 13 Prevnar 13 -- a conjugate containing a pneumococcal bacteria bound to a protein to help the body’s immune system recognize the bacteria and will have a longer lasting immune response. (Currently the only vaccine for pneumococcal bacteria approved in the United States for adults 50 years of age or older is Pneumovax which is only effective against invasive pneumonia and not effective on the more common, pneumococcal pneumonia.)
But at the ACIP meeting (that begins tomorrow and runs through Thursday), there is only a discussion of the 13-valent pneumococcal conjugate vaccine. Just a discussion. While that’s important, a positive recommendation is crucial. Otherwise it is, in many unfortunate respects, just talk.
Coincidentally, today a new study in JAMA (just released today) points to not only the therapeutic benefit of this new adult indication – but also to its cost effectiveness.
A computer-based cost-effectiveness analysis in the February 22/29 issue of JAMA suggests that use of the 13-valent pneumococcal conjugate vaccine (PCV13) might prevent more pneumococcal disease compared with the current 23-valent pneumococcal polysaccharide vaccine (PPSV23) vaccination recommendations -- while remaining economically reasonable.
Kenneth J. Smith, M.D., M.S., of the University of Pittsburgh School of Medicine, and colleagues conducted a study to estimate the effectiveness and cost-effectiveness of pneumococcal vaccination strategies among adults 50 years of age and older. Using various modeling techniques, simulations were performed in hypothetical groups of U.S. 50-year-olds.
(Note: FDA gave pneumovax 50 years and older indication, ACIP recommendation is for 65 years old or older.)
With no vaccination, the estimated lifetime risk from age 50 years onward for hospitalized NPP was 9.3 percent, for IPD was 0.86 percent, and for death due to pneumococcal disease was 1.8 percent. Among the different vaccination strategies compared in the analysis, those using PPSV23 were estimated to prevent more IPD than strategies using only PCV13, while strategies using 2 scheduled PCV13 doses were estimated to prevent more NPP.
Regarding cost-effectiveness, in the base case scenario, administration of PCV13 as a substitute for PPSV23 in current recommendations (i.e., vaccination at age 65 years and at younger ages if co-existing illnesses are present) had an estimated cost of $28,900 per quality-adjusted life-year (QALY) gained compared with no vaccination and was more cost-effective than the currently recommended PPSV23 strategy.
With routine vaccine administration at ages 50 and 65 years, it was estimated that PCV13 costs $45,100 per QALY compared with PCV13 substituted in current recommendations. Administration of PCV13 at ages 50 and 65 years followed by PPSV23 at age 75 years was estimated to cost $496,000 per QALY gained.
The authors’ write that, “There are no absolute criteria for cost-effectiveness, but in general, interventions costing less than $20,000 per QALY gained are felt to have strong evidence for adoption, interventions costing $20,000 to $100,000 per QALY have moderate evidence, and those costing more than $100,000 per QALY have weaker evidence for adoption.”
In an accompanying editorial, Eugene D. Shapiro, M.D., of the Yale University School of Medicine, writes that this analysis provides a reasonable framework with which to approach this issue. “What does seem clear is that improvements in vaccines against pneumococci and increased rates of immunization likely will result in continued reductions in the incidence of infections due to this common pathogen.”
Any further questions?
What makes Bob Temple so endearing (and his opinions so enduring) is his blunt truth telling. Alas, he is often the Cassandra of White Oak.
Recently Temple stated his belief that regulations on product promotion should not impede companies from rebutting findings from comparative effectiveness research involving their products.
This may not sound like a big deal – but it’s a clarion call for those who understand the imperative to systematically and scientifically counter the counter-detailing efforts coming thanks to the tens of millions of tax dollars earmarked for such efforts by the Patient Protection and Affordable Care Act (PPACA).
According to the Pink Sheet, “The subject of asymmetry in the reporting and commenting on CER findings has been a key point of discussion for NPC as CER has taken on a more visible role within the health care debate. Some suggest manufacturers of products subject to CER might have difficulty discussing the findings of the research given FDA restraints on commercial speech.”
Perhaps not.
Speaking at the February 9th conference, Asymmetry in the Ability to Communicate CER Findings: Ethics and Issues for Informed Decision Making (hosted by the National Pharmaceutical Council and cosponsored by the National Health Council and WellPoint), Temple said there is “no FDA view … that drug companies are condemned to silence about their products outside of formal promotion or perhaps published articles. If there’s something published that seems wrong, is based on poorly designed meta-analysis and so on, I don’t see any impediment to answer that and companies do answer that all the time."
Indeed, Bob seemed surprised and displeased that industry has sat by while the grand poobahs of comparative effectiveness share their questionable conclusions.
According to Dr. Temple, “A recent example might be newspaper assertions that antidepressants have no long-term benefit and really don’t work. This has been published repeatedly, and I’d like to see a rebuttal from the people who make antidepressants, because I think the published reports … are wrong. [FDA] may get around to rebutting, but somebody else might want to, and I don’t think there is any impediment to doing that."
Pedal to the metal? Not so fast. Bob qualified his remarks by saying (appropriately) that companies should be mindful of how FDA regulates speech when (and if) they decide to rebut wrong or misleading information from a comparative effectiveness research (whether or not it’s government-funded). “It is clear to me that a sponsor could correct or dispute a CER statement by a payer, or even the government, as long as the correction was not itself promotional."
And there’s the rub. Just what does “promotional” mean – and who is to judge?
Temple gives a good example of how to avoid such a problem:
“In recent months, we’ve seen companies disagree publically with meta-analyses, with epidemiologic conclusions they considered unsupported on methodologic grounds, and that’s OK, although making their own [conclusions] probably would not be."
In other words, it’s not “promotional” to point out a comparative effectiveness study’s design flaws and, therefore, the errors of its conclusions. If such an approach is “compliant,” it opens up tremendous opportunity in countering so-called “academic” detailing.
Or does it? Temple’s is a powerful voice inside the FDA – but it is only one voice. If Secretary Sebelius’ interference in the agency’s Plan B decision is any indication – might not his view be similarly overturned by the mandarins in the Humphrey Building? After all, the comparative effectiveness studies under debate are funded by PPACA and fielded by the Agency for Healthcare Research and Quality (AHRQ). And, to put it bluntly, the current administration has not looked kindly on those who question either its philosophical motives or legislative methods. Industry is deemed guilty until proven guilty. The current modus operandi seems to follow Franz Kafka’s statement that, “My guiding principle is this: Guilt is never to be doubted.”
Which brings us back to the question, what does promotional mean?
A recent paper by Coleen Klasmeier (a former FDA attorney and currently the head of Sidley Austin’s FDA regulatory practice), addresses this issue head on. She points out that “The FDA approach is one of delicate balance – of forbidding off-label promotion without undue incursion into the ability of physicians to obtain information about off-label uses from manufacturers.”
This issue of “undue incursion” seems to dovetail nicely with Bob Temple’s notion of focusing on design flaws and incorrect conclusions. But what of intent?
Well – intent is in the eyes of the beholder. Where one person might see a robust discussion of study design, another might see promotional intent. The foundational problem, as Klasmeier eloquently points out, is the FDA’s reliance on “multifactorial tests rather than bright-line standards.”
Plainly stated, regulators at the FDA (and particularly those who must address thorny First Amendment issues) embrace ambiguity over predictability. It gives them almost limitless power. Industry, on the other hand, wants and needs an evidence-based regulatory framework that provides predictable standards for their communications efforts. Bright lines. Predictability is power in pursuit of the public health. Minus such an effort, we get the troubling example of Par Pharmaceuticals.
In a pending First Amendment suit against the FDA, Par contends the government is criminalizing it’s speech to healthcare professionals about the on-label use of its appetite suppressant Megace ES (megestrol acetate) in settings where doctors prescribe the drug for both approved and unapproved uses.
Par’s complaint, filed Oct. 14 in the U.S. District Court for the District of Columbia, seeks a preliminary injunction against government enforcement of FDA labeling regulations on the grounds they are harming Par’s First Amendment rights by chilling protected speech.
Par’s suit states that physicians more frequently prescribe the drug to treat wasting in non-AIDS geriatric and cancer patients and that the majority of prescriptions for the drug are for off-label uses.
Par also seeks a declaratory judgment that it may speak about the approved use to physicians who could prescribe it for that use, even if they are more likely to prescribe the drug for off-label uses.
“Common sense dictates that the government cannot justify censoring a broad swath of truthful and valuable speech regarding lawful activity out of a desire to prevent other lawful activity,” a memorandum in support of the motion for preliminary injunction states. “And it is absurd to think that the government may imprison a person for engaging in truthful speech about a lawful activity that the government itself subsidizes.”
At issue in Par’s suit are provisions in the Food, Drug, and Cosmetic Act concerning “intended use” of a drug and misbranding.
“If a manufacturer speaks about the on-label use of its drug in a setting where the manufacturer knows that physicians prescribe the drug off-label, the government interprets the FDA’s ‘intended use’ regulations to deem the manufacture to be expressing an ‘objective intent’ that physicians prescribe the drug off-label,” Par’s memorandum states.
In a press release announcing the suit Par said it hoped to “elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, on-label information about prescription drugs to aid in their provision of quality and informed patient care.”
Atlas was permitted the opinion that he was at liberty, if he wished, to drop the Earth and creep away; but this opinion was all that he was permitted. – Franz Kafka
If a company can be challenged when it discusses strictly on-label uses of a product, how much more convoluted, challenging and intimidating will it be to challenge a government-funded and government-detailed comparative effectiveness study?
Disputing comparative effectiveness studies – or any research for that matter -- need not fall into the chasm of promotion (off-label or otherwise). To lump scientific discourse into this slippery silo is to court both agency action and political attention. Alas, as Klasmeier writes, “The off-label problem reflects the accretion of administrative interpretations over the years.”
“Accretion” – otherwise known as mission creep.
Klasmeier continues, “… the commercialization of an investigational new drug is not to be construed to interfere with a manufacturer’s entitlement to engage in scientific exchange.”
And isn’t debating the flaws of a research study scientific exchange -- even if (and especially when) such exchanges raise questions about conclusions that are contrary to any given company’s marketing and sales objectives? How does the issue of intent play into compliance when legitimate scientific exchanges also impact promotional considerations?
On which side should regulators err?
The answer is as easy as it is difficult – regulators should err on the side of the public health. And perhaps the best precedent is FDAMA Section 401, which expressly permits companies to provide reprints of peer-reviewed medical journal articles on off-label studies (as long as they have a pending supplemental application with the agency).
But – as a word to the wise – let’s remember the astute observation of William Blake that, “A truth that’s told with bad intent, beats all the lies you can invent.”
Obama's Nurse Ratched
By Robert M. Goldberg on 2.16.12 @ 6:07AMThe American Spectator
Behind every powerful health care mandate under Obamacare is a power-hungry woman named Kathleen Sebelius. As the Health and Human Services Secretary, she has unprecedented power under Obamacare to control health care decisions, the approval of medical products and the national biomedical research agenda. The Secretary is not only the key player; she is the only one on the field. "The Secretary shall…" is mentioned more than 1000 times in the new health care law.
Sebelius is using that power to promote a liberal agenda and Obama's re-election.
She pushed the contraception edict. Her staff wrote the rules that decided Catholic hospitals and charities are not religious institutions. And she was the one who came up the with the "accommodation" in response to resistance to the mandate: just make the health plans pay for it even if the customers of the plan don't want it.
It is clear Sebelius cares only about imposing a worldview and policies to win support for Obamacare. A reporter asked Sebelius: "If a Catholic nonprofit is paying for your insurance coverage, isn't it paying for contraception if you are getting the coverage through that same insurer?"
Sebelius: "The federal employees health plan… costed this as no cost, free, no cost, because adding contraception and having some employees take advantage of that coverage lowers the overall cost of the health plan."
Free? She will tell insurers to suck up the cost and still force religious organization to offer the benefit. Or else.
This is not an aberration. It is quintessential Kathy: She rules by fiat and if you cross her she will crush you. And when she rebukes and bullies, Sebelius, like Nurse Ratched, claims she is doing so for our own good. As the Big Nurse said: "We do not impose certain rules and restrictions on you without a great deal of thought about their therapeutic value."
In 2002 Sebelius was the insurance commissioner in Kansas and campaigning for governor. She blocked the sale of Blue Cross Blue Shield to Anthem Health because she "thought" doing so would raise premiums. In 2003 when Sebelius was elected, Anthem decided against the merger. (Meanwhile, from 2000-2009 premiums in Kansas rose nearly 100 percent.)
Her use of power during the last days before a congressional vote on Obamacare was also Ratched-like in nature: Sebelius told the Association of Health Insurance Plans: "You can choose to continue your opposition to reform. If you do and reform goes down in defeat, we know what will happen." She threatened insurers that if they continued to blame their rate increases on the new health overhaul they could be excluded from health insurance exchanges.
Sebelius subsequently hauled in health plan execs in 2010 to explain why premiums were going up by 10-20 percent in certain states. And she tried to censor one health plan altogether when it sent a letter to Medicare customers about premium increases. She explained she was only doing this in ensure everyone gets basic care. Or a Nurse Ratched would say: "I tell you this hoping you will understand that it is entirely for your own good that we enforce discipline and order."
Last year Sebelius appeared at several fundraisers for Democrat congressional candidates and the 2012 re-election effort. Sebelius broke all campaign spending records in the 2006 re-election bid and she is regarded as a fundraising machine. In part this is due to the fact that the used the power of her office to punish enemies and reward pals. As HHS Secretary she has the power to mandate coverage, exclude health plans, reject payment for new technologies. She has shown she's not afraid to use this power to shake down and intimidate groups holding views contrary to her own and reward her allies. And since the Independent Payment Advisory Commission reports to her, she has absolute control over what Medicare and Medicaid will pay for in the years ahead.
Which is why Sebelius (who attacked Super PACs in 2010) is one of Obama's most important surrogates in the effort to raise outside money for his re-election. She has spoken at Planned Parenthood and the National Abortion Rights Action League events. Sebelius has attended fundraisers for several politicians over the past two years. And in the process she will use Obamacare as both carrot and stick to get her way.
Illinois State Reps. Ann Williams (D) and Edward Acevedo (D) introduced a bill in the state's General Assembly that would limit the substitution of a biosimilar for a prescribed product by Illinois pharmacies. The bill (HB5581) would permit substitution only when five criteria are met: the biosimilar has been determined by FDA to be interchangeable with the prescribed product; the prescribing physician does not specifically prohibit substitution; the patient provides written consent for the substitution; the pharmacist notifies the prescribing physician in writing within 24 hours after the substitution; and the pharmacy and the prescribing physician retain a written record of the substitution for no less than five years.
ABC News
Cancer patients are furious that a counterfeit version of the drug Avastin has landed in U.S. clinics.
Avastin, which is made by the California-based company Genentech, is used in combination with chemotherapy to treat cancers of the colon, brain, kidneys and lungs. But the counterfeit lacks the tumor-starving ingredient some patients need to survive.
"It's an outrage," said Diane Barraza, 48, who takes Avastin for stage IV colon cancer. "For a company to sell this drug, put it in our blood, it's an outrage."
The U.S. Food and Drug Administration announced Tuesday that 19 clinics in California, Texas and Illinois may have purchased the phony Avastin from Quality Specialty Products, an "unapproved" foreign supplier also known as Montana Health Care Solutions. The counterfeit vials are labeled "Avastin" but indicate "Roche" as the manufacturer. Roche is the parent company of Genentech.
"The counterfeit contains no Avastin, no generic Avastin, no active ingredient whatsoever," Genentech spokesman Ed Lang told ABC News. Lang said the contents of the vials are still under investigation.
For patients like Barraza, a fake cancer drug would be the cruelest con.
"To sit in the chemo chair and watch that stuff drop into my veins," said an emotional Barraza, who lives in Fullerton, Calif., with her 6-year-old daughter. "It's all I've got. And it might just be water?"
Avastin is expensive, costing upwards of $650 for a small vial. But Montana Health Care Solutions sold the counterfeit vial for $480, according to one of the clinics -- a cost savings of 25 percent.
"Obviously it makes good business sense to try to get the drug at a reduced cost," said Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif. "But when you start to get drug pricing that's markedly different from that of the standard distributor, it should raise a red flag."
Only four U.S. distributors are authorized to sell Avastin to doctor's offices; another four can sell the drug wholesale to hospitals. Montana Health Care Solutions is not an authorized Avastin distributor. Jacoub, who treats Barraza, said his clinic buys Avastin in bulk from an approved distributor for $593.20.
Montana Health Care Solutions claimed to be based in Belgrade, Mont. But the company's recently disconnected phone number has a New Brunswick, Canada, area code. It's unknown whether Montana Health Care Solutions knew the Avastin was counterfeit. They also sold other cancer drugs, including Neulasta and Faslodex, at a significantly discounted price.
The FDA was alerted to the possible counterfeit in December 2011 by the Medicines and Healthcare Products Regulatory Agency in the U.K., according to Genentech's Lang. In a Feb. 10 letter, the agency urged the 19 clinics known to have purchased through unapproved distributors to "retain and secure" any unused drugs. The counterfeit Avastin vials have the lot numbers B86017, B6011, B6010, and the labels are slightly different.
Counterfeit or illegally imported drugs are rare in the U.S. but not unheard of. In 2008, heparin (a blood thinner) imported from China killed 81 Americans.
"Counterfeit drug makers have reached a level of sophistication where the real and fake products look almost identical," said Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner for the FDA. Pitts estimated that counterfeit drugs generated $75 billion in 2010, a figure expected to grow by 20 percent annually. "It's a low risk, high reward proposition. It's almost a perfect crime -- people aren't getting the drugs they need and they end up dying."
For Barraza, who will have four more Avastin treatments over the next two months, the thought of criminals profiting from her disease is sickening.
"I wish they could understand what it feels like to be a cancer patient, to take a drug and to suffer," she said. "I'd do anything to stay alive, but I need the right medication."
Read the full article here.
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.
