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Counterfeit Drugs: A Growing Global Health Crisis

June 16th, 2009 by Dr. Val Jones in News, Quackery Exposed
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A resistant strain of bacteria –created by partially effective counterfeit antibiotics – doesn’t need a VISA and passport to get to the U.S.

–    Paul Orhii, National Agency for Food and Drug Administration and Control, Nigeria

I attended a conference in DC yesterday called, “The Global Impact of Fake Medicine.” Although I had initially wondered if homeopathy and the supplement industry would be the subjects of discussion, I quickly realized that there was another world of medical fraud that I hadn’t previously considered: counterfeit pharmaceuticals.

Just as designer goods have low-cost knock-offs, so too do pharmaceuticals and medical devices. Unfortunately, counterfeit medical products are a higher risk proposition – perhaps causing the death of hundreds of thousands of people worldwide each year.

It is difficult to quantify the international morbidity and mortality toll of counterfeit drugs – there have been no comprehensive global studies to determine the prevalence and collateral damage of the problem.  But I found these data points of interest (they were in the slide decks presented at the conference):

–    Pfizer Global Security raids resulted in seizure of 11.1 million counterfeit tablets, capsules and vials in 42 countries in 2008. Pfizer seizure of counterfeit drugs in 2008 were up 28.9% over 2007.

–    Within a 7 day period, 250 different Internet-based Viagra purchases were seized in a single mail center. After chemical testing, it was determined that 100% of the tablets were counterfeit.

–    Anti-malarial counterfeit tablets are common in East Asia and Africa, threatening to derail the US goal of decreasing malaria mortality by 50% in 15 countries. Chemical testing in Africa revealed that 20-67% of chloroquine failed content quality checks, and 75-100% of sulfadoxine-pyrimethamine tablets (for pregnant women) was not absorbable. Tests conducted in Cambodia in 2003 demonstrated that 27% of anti-malarials were counterfeit with quinine being 77% counterfeit and tetracycline 20% counterfeit.

–    Some “Canadian” mail order pharmaceutical prescriptions have very circuitous routes of manufacture, packaging, and delivery. One batch was manufactured in China transported to Dubai, then to London, then filled in Bahamas, sent to the UK, and then mailed to the US.

–    Counterfeit drugs are estimated to make up 30% of Kenya’s total pharmaceutical products, 20% of India’s, 10% of Russia’s, and <1% of US.

–    Most counterfeit medications found in the US supply chain seem to be introduced through Internet purchases.

–    The global active pharmaceutical ingredient production was estimated at $70 billion in 2008. China and India account for 60% of production

–    70% of all generic medications are manufactured in India. It is estimated that the Indian global generic business will grow to >$70 billion by 2009. India and China have much less stringent safety and regulatory standards, which provides fertile soil for counterfeiters.

–    25 years ago, most counterfeit medications were placebos. Today’s counterfeits have some active ingredients because sophisticated counterfeiters are looking for repeat business.

This conference provided a sobering account of the counterfeit pharmaceutical industry, tracking its exponential growth over the past two decades. That growth appears to be fueled by the outsourcing of pharmaceutical manufacturing plants to countries with limited regulatory oversight, and the sale of medications via the Internet.  So far, poor quality and contaminated prescription drugs are rarely found in US pharmacies – but that could certainly change. The FDA, US Department of Commerce, and US Agency for International Development are calling for an international public-private partnership to stem the tide of counterfeit drug manufacturing. But with little to lose (fines for counterfeit drug manufacturing are notoriously light) and much to gain (a slice of a multi-billion dollar industry), it’s unlikely that the counterfeiters are going anywhere anytime soon.

*This blog post was originally published at Science-Based Medicine*

Futile Care: A Sad Case Of Wasted Resources

June 15th, 2009 by KevinMD in Better Health Network
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A 90-year old man with a pancreatic mass, almost definitely pancreatic cancer, was admitted to a hospital.

Surgeon Jeffrey Parks does the initial surgery consult on this terminal case, and recommends hospice care.

The next evening, he’s shocked by the “astounding amount of medicine [that] had been practiced” during the day:

Consults had gone out to GI, oncology, and nephrology. The GI guy had ordered an MRCP and, based on some mild distal narrowing of the common bile duct, had scheduled the patient for a possible ERCP in the morning. A stat CT guided biopsy of the liver lesions had also been done. The oncologist had written a long note about palliative chemotherapy options and indicated he would contact the son about starting as soon as possible. The nephrologist had sent off a barrage of blood and urinary tests.

It’s often said that we spend the most money in the world on futile care, often with little benefit to the patient. The preceding account was that phenomenon in action, replicated thousands of times on a daily basis.

A microcosm of what’s wrong with American medicine indeed.

*This blog post was originally published at KevinMD.com*

Contaminated Beachwater May Be Hazardous To Your Health

June 15th, 2009 by Paul Auerbach, M.D. in Better Health Network, Health Tips, News
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Summer has arrived and so many of us are headed for the beaches that line the coasts of the United States as well as those of our inland waters, such as lakes and rivers. There are plentiful healthcare concerns for beachgoers. These include sunburn, drowning, jellyfish stings, sprains, strains, and cuts and bruises. What perhaps doesn’t receive as much attention as it deserves is ocean water quality – specifically, whether or not the water is contaminated by environmental toxins and/or harmful bacteria.

Nearly a year ago, reports circulated in the press that indicated that at least 7% of beach water samples in the U.S. exceeded acceptable (from a health perspective) levels of bacteria. A writer for the New York Times reported, “The number of beach closings and health warnings issued to swimmers as a result of pollution fell in 2007 from a record level in 2006,” according to the Natural Resources Defense Council (NRDC). But the writer continued that the NRDC noted “that American beaches ‘continue to suffer from serious water pollution that puts swimmers at risk.'” He cited that the NRDC analyzed “data obtained from the Environmental Protection Agency on more than 3,500 beaches,” revealing “that beaches across the country closed because of pollution or issued pollution-related health advisories for a total of more than 22,000 days in 2007, down from more than 25,000 days in 2006.”

A reporter for the Los Angeles Times wrote that the NRDC found that “Los Angeles County is home to the dirtiest beaches in the state (California), with repeat offenders Avalon on Santa Catalina Island and Santa Monica among those with the highest levels of fecal bacteria in ocean water.” Overall, the NRDC found that, “Illinois has the most coastal beaches in the country with water samples exceeding acceptable levels of (potentially harmful) bacteria, such as E. coli.”

The NRDC posts an informative page on beach pollution. The major takeaway is that the beachgoer should be well aware of the current situation with regard to pollution or contamination of any body of water for which human entry is contemplated.

Here is the status of the federal Beach Protection Act of 2008, as reported by OpenCongress:

Read more »

This post, Contaminated Beachwater May Be Hazardous To Your Health, was originally published on Healthine.com by Paul Auerbach, M.D..

Healthcare Reform Views From A Flaming Moderate

June 15th, 2009 by DrRob in Better Health Network
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I am a flaming moderate.  Yes, I know that is an oxymoron but the fact remains that I am both passionate and moderate in my political opinions.

And I am in the mood to rant, so beware.

Living in the deep south, I often seem like a radical communist to those I see.  I frequently get patients asking questions like “So what do you think about Obama’s plans to socialize medicine?”, or “I wanted to get in here before Obama-care comes and messes things up.”  I usually smile and nod, but find myself getting increasingly frustrated by this.

The house is burning down, folks.  Healthcare is a mess and desperately needs fixing.  How in the world can someone cling to old political yada-yaya-yada when people are dying?  I am not just talking about the conservatives here because to actually fix this problem we all have to somehow come together.  A solution that comes from a single political ideology will polarize the country and guarantee the “fix” to healthcare will be one constructed based on politics rather than common sense.

No, this doesn’t frustrate me; it infuriates me.  The healthcare system is going to be handed over to the political ideologues so they can use it as a canvas for their particular slant.  In the mean-time, people are going to be denied care, go bankrupt, and die.  Yes, my own livelihood is at stake, but I sit in the exam room with people all day and care for them.  I don’t want to be part of a system that puts ideology above their survival.

So here is what this radical moderate sees in our system:

1. The payment system we have favors no one. Every single patient I see is unhappy with their health insurance to varying degrees.
2. Stupid and wasteful procedures shouldn’t be reimbursed. This is business 101; if you don’t control spending, you will not be able to sustain your system.  This means that we have to stop paying for procedures that don’t do any good.  Some will scream “rationing” at this, but why should someone have the right to have a coronary stent placed  when this has never been shown to help?  Why should we allow people to gouge the system for personal gain in the name of “free market”?  I got a CT angiogram report on patient today who has fairly advanced Alzheimer’s disease.  I twittered it and the Twitter mob was not at all surprised.  These things happen all the time.  The procedures do no good and cost a bundle.  The procedure done today probably cost more than all of the care I have given this patient over the past 5 years combined!
3. The government has to stop being stupid. Why can’t I give discount cards to Medicare patients?  Why can’t I post my charges, accept what Medicare pays me, and then bill the difference?  The absurdity within the system is probably the best argument against increased government involvement.  Who invented the “welcome to Medicare physical??”  I never do it because the rules are utterly complex and convoluted.  If the rules can be this crazy now, how much worse will it be when the government takes over?  If my medicare patients are confused now, how much more will we all be if the government grabs all of the strings?
4. The money is going somewhere. In the past 10 years, my reimbursement has dropped while insurance premiums have skyrocketed.  There are more generic drugs than ever and I am no longer able to prescribe a bunch of things that didn’t get a second-thought 10 years ago.  Hospitals stays were longer and procedures were easier to get authorize.  So where is the money going?? We do know the answer to this question – there is no single culprit.  Drug companies were to blame for a while, but now they are going to the dogs; and yet the rates aren’t dropping.  The real problem is that there are far too many people trying to capitalize on the busload of money in healthcare.  Shareholders, CEO’s, and simple corporate greed has bled money out of the system like a cut to the jugular.
5. Docs have to stop being idiots. We like our soap boxes to rant against EMR, malpractice lawyers, drug companies, and insurance companies.  We stand on different sides yelling our opinions but don’t come up with solutions.  Instead of doing what is right for our patients, we join the punching match of politics.  Is EMR implementation important?  Duh!  There is no way to fix healthcare without it.  But the systems out there are designed by engineers and administrators and don’t work in the real life.  So why can’t we computerize ourselves?  Every other industry did.  Why must we cling to the archaic paper chart because we don’t like the EMR’s out there?  Aren’t we smart people?  Aren’t we paid to solve problems?  Stop throwing darts and start finding solutions.  Med bloggers are terrible in this – they rant constantly against EMR, but don’t ever say what would work.  It’s fun to criticize, but nobody wants to propose an alternative.
6. We need to get our priorities right. Healthcare is about the health of the patient.  Yes, it is a job for a lot of people.  Yes, it is an investment opportunity.  Yes, it is a good thing to argue about – whether it is a “right” or not.  Yes, it is a major political battleground.  But in the end, these things need to be put behind what is most important.  As it stands, we are more passionate about these other things than we are about the people who get the care.  In the end it is about making people well or keeping them that way.  It is about saving lives and letting people die when it is time.  If we were all half as passionate about what is good for patients (and we are all patients) as we are about these other issues, we wouldn’t have half of the problems we have.

As a flaming moderate I get to offend people on all sides.  We need to fix our system.  It is broken.  It is not a playground for those who like to argue.  It is not a place to be liberal or conservative.  This is our care we are talking about, not someone else’s.  The solution will only come when we all come to the table as potential patients and fix the system for ourselves.

Is it easy?  Heck no.  This rant is not meant to show I am smarter than the rest of you; it is meant to get all of us away from the other issues that make any hope of actually fixing our problem remote.  Given the fact that we all are eventually patients, our political posturing and plain stupidity may come back to haunt us.  No, it may come back to kill us.

*This blog post was originally published at Musings of a Distractible Mind*

Hot Topics In Healthcare Reform: A Primer

June 15th, 2009 by Gwen Mayes, J.D. in Health Policy, News
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For those of who believe there is a pill for every ill, the recent flurry of legislation and ensuing debates on health care reform may be just too big a pill to swallow.

You’ll need a very large glass of water for sure.

“There’s a lot to consider and not everyone is going to like everything about this legislation,” Rep. Lois Capps (D-CA) told participants at Avalere Health’s conference on Raising the Bar:  Payment Reform and CV Disease on Friday, June 12 in Washington.  Capps, a 20 year veteran school nurse, co-chair of the Democratic Heart and Stroke Caucus and member of the House Energy & Commerce Health Subcommittee describes the pending legislation in terms of “choice” and “a balance” but readily admits that finding a way to pay for it will be difficult.

For those who might not feel up to speed on the latest buzz on health care reform, here’s a quick primer:

Public Option. To cover the 47 million uninsured or underinsured Americans, the President is asking for a public plan that would compete within the insurance market place either directly on cost, or indirectly with clout.  Supposedly, this plan (yet to be included in the Senate HELP health reform legislation introduced last week but rumored to be coming in the markup) will be subject to the same rules and regulations of the private health insurance market.  It could be an extension of Medicare, Medicaid or a hybrid of approaches involving capitation and integrated systems for physicians and hospitals.

The debate about whether or not to introduce a new public option to the current health insurance system involves more than a sense of fairness or simply closing the gap.  The private insurance business is strongly tied to state regulations and competitive forces that will remain as long as 15% of Americans purchase their insurance out of pocket and another 40% have insurance through employment .  Designing the right form of public assistance that can compete with private insurance but not control the market place is surely to reflect the strong differences between political parties.

Centralists in Congress, namely Sen. Kent Conrad (D-ND), have proposed co-ops as a third approach between a public option and the status quo.  Co-ops are membership-owned and operated non-profit organizations that adhere to state laws for health care coverage and provide health insurance for individuals and small businesses.  Reaction has been mixed but some believe co-ops will hit the right balance of competition and public assistance needed for passage in the Senate.

Comparative Effectiveness. Comparative effectiveness research seeks to compare the clinical effectiveness of two alternative therapies for the same condition.  It’s rooted in the idea that our system of paying for the volume (e.g., “fee-for-service”) should be replaced with payment for effectiveness and value that is based on the best science possible.  Recent examples of comparative effectiveness research include trials comparing bare metal coronary stents to drug-eluting stents and comparing older versus newer drugs for treatment of schizophrenia.   All this can be extremely valuable to clinicians and patients trying to decide between alternative courses of treatment.  And to the extent that comparative effectiveness research improves the quality of care, it can also reduce costs.

But clinical data alone cannot reflect patient preferences or whether a treatment course for the overall population is the best one for an individual.   The hot button here is how to encourage clinical research that can help physicians and patients make the best treatment choices yet safeguard it from being used by insurance companies and the government to deny coverage or set payment.  What, exactly, will be compared needs close scrutiny.

Accountable Care Organizations (ACOs). An ACO is a combination of one or more hospitals, primary care physicians and possibly specialists, who are accountable for the total Medicare spending and quality of care for a group of Medicare patients.   Various carrots and sticks are being discussed, but the idea is to control Medicare spending and improved quality of care.  While most physicians recognize the need to move away from Medicare’s fee-for-service approach, the incentives and infrastructure needed to coordinate among providers isn’t apparent.  What about rural areas where coordination of care is a misnomer?  This may be a hot topic for systems change, but practitioners are skeptical.

Patient-Centered Care. It’s hard to imagine that the American College of Cardiology felt the need to launch a new initiative, the “Year of the Patient” or the British Medical Journal depicted tango dancers on its cover story, “Partnering with the Patient” but re-infusing the health care debate from the patient’s perspective is long overdue.   Look for it in every piece of legislation, new commission and advisory group.  Raising the voice of a few on a plum commission or panel discussion  is a laudable start, but we’re all, at one time or another, patients.  We’re all consumers of health care and drawing upon our own experiences to improve our professional stance will be necessary.

Gateways. The Senate HELP Committee’s legislation introduces the concept of “gateways” or “exchanges”, a clearinghouse of sorts on a state level to help consumers parse through insurance plans and public services.  The program would be optional for states for the first six years then federal compliance would prevail.  Organizations such as Kaiser Family Foundation have already established online “gateways” (www.healthreform.kff.org) to inform consumers wanting to know more.

Health reform is coming fast and furious.  On Monday, June, 15, the Congressional Budget Office is expected to release their projections on what it will take to pay for such massive reforms.  Hospitals and physician groups are deeply concerned about cuts in Medicare payments – estimated by the President on his weekend radio chat as an additional $313M on top of the $309M included in the Administration’s FY2010 budget.

Further legislation will be released this week; keep an eye on the Senate HELP Committee, Senate Finance Committee, House Energy & Commerce, House Ways & Means, and House Education and Labor.

There’s much more to health reform than covered here.  I encourage you to find a passion point of entry and share your insights.

And get ready to swallow a very big pill.

Here’s a quick list of what’s hot in health care reform:

• Public Option
• Electronic Medical Records
• Elimination of pre-existing exclusion
• Patient-Centered Care
• Accountable Care Organizations
• Payment based on value not volume
• Integrated health delivery systems
• Federal Health Board
• Transparency in data, costs and outcomes
• Personalized health care/personalized information
• Chronic care models/Transitional Care Models
• Prevention and wellness programs
• Comparative Effectiveness
• Payment reform/Medicare cuts
• Shared decision making