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Counterfeit Drugs: A Growing Global Health Crisis

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):
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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Is IV Sedation Over-Used?

We criticize alternative medicine for not being evidence-based, and they criticize conventional medicine in turn, saying that much of what conventional medicine does is not based on evidence either. Sometimes that criticism is justified. I have run across a conventional practice that I suspect began because it sounded like a good idea, but that never was adequately tested and is not carefully thought out for individual patients.

I recently had a bone marrow aspiration. The written instructions said not to eat or drink for 6 hours before the procedure, to bring someone to drive me home, and to expect an IV. I suspected from these instructions that they were planning to use IV sedation, and I was right.

I questioned the need for sedation. I am prejudiced about bone marrow aspirations. I observed several and did one myself during my internship. When I had finished, the patient asked me when I was going to start. We did the procedure at the patient’s bedside in a multi-bed ward with no sedation, only local anesthesia. So my prejudice was that the procedure was no big deal and was not terribly painful.

I can imagine that some patients may be terrified by the idea of a needle going into their bone and may want to be sedated and not remember the experience. But I was not anxious about it, and I saw no need for the fentanyl and Versed they wanted to give me. I figured it would only prolong my time in the hospital, produce amnesia, expose me to a small risk of adverse effects, and leave me groggy; so I asked to opt out. They readily agreed – although they did keep asking me if I was really sure I didn’t want it. They would not have offered the option of no sedation if I had not known to ask. (more…)

Posted in: Pharmaceuticals, Surgical Procedures

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Book Review: Triumph Of The Heart, The Story Of Statins

Triumph of the Heart, as its name does not suggest, is about science. The book’s author, Jie Jack Li, is a medicinal chemist who meticulously reviews the history relevant to the discovery of lipid-lowering drugs. He spares no details, even recounting the amusing quarrels and quirks of the scientists engaged in the “apocryphal showdowns” leading to the manufacture of cholesterol in a laboratory.

The personalities of the various scientists and Nobel laureates described in the book are highly entertaining. From beating one another with umbrellas, to insisting on wearing blue clothing only, to egos so large and unappealing as to empty an entire academic center of all its promising young recruits, one has the distinct impression that brilliance does not go hand-in-hand with grace.

That being said, each of these scientists did seem to share a common approach to research: carefully testing hypotheses, repeating peer study results to confirm them, and patiently exploring complex biochemical pathways over periods of decades. The physicians, physicists, and chemists showed an incredible ability to doggedly pursue answers to specific questions – understanding that the results might influence human health. But even more importantly, they were each willing to invest their careers in analysis that may never lead to anything more than a dead end. In fact, the book is full of examples of great ideas, developed over decades, that did not lead to a marketable drug. In some cases the research was halted due to lack of efficacy, in others political forces or personal whims influenced the course.
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Posted in: Book & movie reviews, Pharmaceuticals

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When fraud undermines science-based medicine

The overriding them, the raison d’être if you will, of this blog is science-based medicine. However, it goes beyond that in that we here at SBM believe that science- and evidence-based medicine is the best medicine. It’s more than the best medicine, though; it’s the best strategy for medicine to improve therapy for our patients. We frequently contrast science-based medicine with various forms of “complementary and alternative medicine,” specifically pointing out that SBM changes its practices as new science and new evidence mandates it while CAM tends to rely on ancient, vitalistic, pre-scientific or pre-modern scientific beliefs about how disease occurs as the basis for its therapies. Although it may be painfully slow and frustrating at times and even though there may be major stumbles along the way, the overall course of SBM over the last century has in general been to produce ever more effective therapies and to discard therapies that are either ineffective or whose risk-benefit ratios are insufficiently favorable. The one single most important thing behind the advancement of medicine is good science.

That’s why I really, really hate scientific fraud, and I’m really, really upset, perhaps even more so than Dr. Atwood, over the discovery last week of what is arguably one of the most massive scientific frauds in medical history. It doesn’t matter that Dr. Atwood is an anaesthesiologist and I am not, meaning that the specific scientific fraud unearthed, which was perpetrated by an anesthesiologist studying multimodal anesthesia, as reported in Anesthesiology News, the Wall Street Journal, and the New York Times. I am a surgeon, and the relief of surgical pain in my patients is an important part of my practice. If the scientific basis of what my colleagues in anesthesiology do before, during, and after my operations is called into doubt, I have to wonder if I am giving my patients the best surgical care. Aside from that, there is the intellectual outrage I feel as a result of seeing science and patients betrayed in such a systematic and blatant manner.
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Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine, Surgical Procedures

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Scientific Fraud Hits Home

Last week the story broke that Scott Reuben, an anesthesiologist and clinical researcher at Baystate Medical Center in Springfield, MA, had falsified data in at least 21 publications over a period of at least 12 years—making it one of the most enduring examples of scientific fraud in memory. Almost all of Reuben’s papers had reported innovative methods for providing post-operative pain relief (analgesia); many of them involved ‘multimodal’ regimens for painful orthopedic procedures such as spinal fusions and total knee replacements. Recent papers reported regimens that included celecoxib (Celebrex) and pregabalin (Lyrica), both made by Pfizer. Much of Reuben’s research had been funded by Pfizer, and Reuben has been a member of the Pfizer speaker’s bureau (that information is included because the reader would otherwise wonder, but there is no indication that Pfizer has been intentionally involved in Reuben’s fraud).

I will not discuss this case in detail; look for a more comprehensive piece on SBM next week. Rather, I present it now to offer a local example of how such a breach of trust affects those who rely on clinical research to inform their care of patients.

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Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine

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Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug –  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

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Posted in: Pharmaceuticals, Politics and Regulation

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Comparative Clinical Effectiveness Research: Good News In Shades Of Gray

When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation, Public Health

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The Anniversary

I received a surprising morning call several weeks ago

“Wally?”

“This is he.”

“This is Judy V…. I just wanted to call and thank you again for what you did for me. It’s the 35th anniversary of my cancer…“

Judy V. is a physician’s widow. Her husband, a surgical specialist died in his 40s, 20plus years ago.   She had a Stage II breast cancer; the surgeon had done a modified radical, and I was consulted for possible adjuvant chemotherapy.

Thirty-five years ago the standard was simpler. Same for our knowledge of staging and biological behavior. Genomics was not a word yet. Targeted therapy was not a concept. Tamoxifen was the ony estrogen agonist and had just been introduced.  The standard adjuvant therapy was single agent melphalan or its equivalent. But even then, patients had choices. The surgery had probably cured her, but then… Chemo or none.
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Nutrition, Pharmaceuticals, Politics and Regulation

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Historic College of Pharmacy to Honor Homeopathy Leader

I am a graduate of the institution known formerly as the Philadelphia College of Pharmacy and Science (PCP&S) – the first college of pharmacy in North America, established in 1821.  The college, now called University of the Sciences in Philadelphia, counts among its alumni John Wyeth, Silas M. Burroughs, Sir Henry Wellcome, several members of the Eli Lilly and McNeil families, and other historical figures in pharmacy among founders of what have now become large pharmaceutical companies.

Although I was among the 35% of students in the “and Science” side of PCP&S, earning a BS in Toxicology, I was there at a time before Big Pharma had acquired much of the bad name it often carries today and we took great pride in our college’s rich history and contributions to modern medicine.  In particular PCP&S graduates were critical players in combating snake oil hucksters in the early 1900s and establishing chemical standards, safety, and efficacy guidelines for therapeutic agents.

So it is with disbelief that I learned my alma mater plans to award an Honorary Doctorate of Science to a major leader in homeopathy – on Founders’ Day, no less.  The press release is here.

I’ve just sent the following e-mail to University President, Philip P. Gerbino, Pharm.D., and Provost Russell J. DiGate, Ph.D.:

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Posted in: Homeopathy, Pharmaceuticals, Science and Medicine

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The Debate About Off-Label Prescriptions

So-called off-label uses of prescription drugs is an enduring controversy – probably because it involves a trade-off of competing value judgments.The FDA is considering loosening its monitoring of off-label prescriptions, but critics are charging that, if anything, regulations should be tightened. Many issues of science-based medicine are at the core of this controversy.

In the US the FDA (Food and Drug Administration) regulates the sale of drugs. In order for a pharmaceutical company to get a drug on the market they must complete FDA monitored clinical trials and demonstrate adequate safety and effectiveness for a specific indication. The specific indication for which a drug is approved is the on-label indication, and all other uses are off-label.

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Posted in: Pharmaceuticals

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