LifeCare Chiropractic

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Drug Research

Drug company fined for excessive hospitality – (03-01-01)

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Drug company fined for excessive hospitality

Do I really need to comment on this?? All decisions for patient care should be made with one question in mind: Will this benefit my patient? This decision should be unadultered with memories of extravagant trips, daily lunches at the office, free continuing education seminars and ads seen everywhere imaginable. Pharmaceutical marketing to the public SHOULD NOT have an impact on prescribing habits. Every doctor should review the evidence from an independent and unbiased source to determine its safety and effectiveness. Maybe you could actually consider the lack of gigantic advertising budgets for nutriceutical companies a good thing–the physician then relies on medical research and personal experience to make recommendations to their patients.

bmj.com Sheldon 322 (7283): 382b

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NCCAM Director Foresees Slowdown in Alternative Medicine Grants – (02-15-01)

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NCCAM Director Foresees Slowdown in Alternative Medicine Grants

$89.1 million is 2001 budget the National Advisory Council for Complementary and Alternative Medicine to be given out for research grants. Compare this budget to NIH’s overall budget. Not much of a dent. So we have a small percentage of money going to CAM research and now reduced approval of incoming grants. And mainstream medicine loves to comment on how there is no research on CAM therapies. That’s because there’s pennies for research compared to the money that the pharmaceuticals can produce for researching their products. But we do have, in some cases, thousands of years of experience….

(article) After an initial few years of budget growth and an increase in grant awards, the National Center for Complementary and Alternative Medicine (NCCAM) will cut the number of new grants for fiscal 2001, center director Stephen Straus said on Monday. “We’re going to slow down the pace of new initiatives,” said Straus, whose center is a division of the National Institutes of Health (NIH). Outlining the state of the NCCAM to the National Advisory Council for Complementary and Alternative Medicine here, Straus explained that despite a generous increase in its budget for the fiscal year, which began on October 1, the center’s previous grant commitments mean that there will be less room for new awards. The NIH gave NCCAM $89.1 million for fiscal year 2001 compared to $68.3 million in 2000. In terms of awards, about 35% of the budget will go toward research grants, 23% to designated centers of excellence — which are organized to study specific disease states or categories — and 10% to training current providers and educating new providers. The remainder will be allocated toward administration and other initiatives. In 1999, the year NCCAM was founded, it was easy to award grants, said Straus, noting they were usually “low-hanging fruit” and of high caliber. Almost half of the 23 applications that year were awarded, he said. In fiscal year 2000, 31% of 144 applications were granted, which was in line with the overall NIH average that approved 26% of 33,000 applications in that fiscal year. This year, the NCCAM estimates it will receive 212 applications, but will likely support only 18%, partly because of budget constraints held over from funds granted in 1999 and 2000, but also because of quality concerns, Straus said.

 

Potential Adverse Effects of Alternative Rx ‘Growing Exponentially’ – (01-27-01)

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Potential Adverse Effects of Alternative Rx ‘Growing Exponentially’

There are several ways to look at this article. First, the list of adverse effects (potential, actually…) could keep growing exponentially for many years and still not touch the numbers associated with pharmaceutical drugs. On the other hand, we really do need to come to terms with the power of natural medicine and stop taking it so lightly. There are many, and I would venture to say most, patients using a specific natural medicine based on something their neighbor told them or they read in Reader’s Digest. It’s not that easy, and almost always, involves some aspect of lifestyle changes to augment the therapy, such as consistent exercise.

(article) The number of known nutrient-to-nutrient and nutrient-to-drug interactions is growing exponentially, panelists said here Monday at a complementary and alternative medicine symposium at the American Society for Parenteral and Enteral nutrition’s 25th Clinical Congress. Though herbs and plants have been used to treat medical conditions for thousands of years, “we don’t know what effect our culture has on these herbs,” warned Georgia M. Decker, a nurse practitioner at Integrative Care in Albany, New York. The speakers emphasized that even benign-sounding herbs can be dangerous in combination with other therapies or if taken by patients with certain diseases. For example, garlic can worsen a hypoglycemic patient’s symptoms, and ginger should not be taken by patients with gall bladder disease. Another drawback is that alternative therapies sometimes mask patients’ symptoms and thus their underlying diseases. That means patients need to be asked not only what they are taking, but how much, panelists said. “Licorice wafers do help settle the stomach when there’s a lot of acidity,” Decker explained. “But if somebody is saying to you, ‘Oh, I take five, six licorice wafers a day,’ then what’s the gastrointestinal symptom that would require five or six wafers a day?” The presenters encouraged healthcare professionals to continue to learn what they can from the literature that is available. “We simply cannot say, ‘No, you can’t take that,’ because there aren’t several big prospective randomized trials that have come to the same conclusion,” said Kathryn K. Hamilton, a registered dietitian and instructor at Columbia University in New York. “In all likelihood, these trials are not going to happen.”

Prescription drug shortages plague US – (01-22-01)

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Prescription drug shortages plague US

This is supposed to be a bad thing, a “plague?” In many cases I would consider this a blessing. A ridiculous example given involves oxytocin, a drug used to induce labor. Brigham and Women’s Hospital in Boston uses this in “almost every one of its 10,000 annual deliveries.” (What ever happened to nature???) The truly ironic quote by Dr David Acker, the hospital’s chief of obstetrics, was that, when doctors had to cut back on their use of the drug, “Fortunately no patient suffered.” Okay, okay. So WHY do we use it at all?? No patient suffered because they did not have a drug to try to best nature? Forward this one to any midwives you know and they’ll pass out laughing….

bmj.com Charatan 322 (7279): 130a

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Volunteer’s Death Prompts Review – (07-02-01)

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Volunteer’s Death Prompts Review

Think this one will pass FDA approval? You might be surprised… All kidding aside, just remember that many times the general public serves as the true guinea pigs for many new drugs. The list of drugs that were pulled off the market after dangerous side effects were found after the drug was approved is quite long. The ironic thing is that many natural compound have literally thousands of years of safe use and yet their use is looked upon with skepticism by much of the medical community.

Science — Marshall 292 (5525): 2226b

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FDA Warns Against Use of Product That Phyne Will Not Recall – (02-12-01)

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FDA Warns Against Use of Product That Phyne Will Not Recall

This article seems strange. The FDA has ordered a recall, but the recall of one of the items, inject-able adrenal cortex extract, is not going to be done by Phyne Pharmaceuticals. Kind of makes you wonder who’s in charge… Ironically, the recall was due to substandard manufacturing processes. Instead of using this potentially unsafe extract, I would consider using glandulars long before I would consider using an inject-able extract. Glandulars are purified portions of organs from healthy tissue (usually bovine) . If you want to support a gland in the body, instead of figuring out all the potential micronutrients necessary for optimal functioning, glandulars are the best answer.

(article) The US Food and Drug Administration (FDA) issued on Monday a strong recommendation against the use of injectable adrenal cortex extract (ACE) manufactured by AMRAM Inc. and marketed by Phyne Pharmaceuticals. A recall of ACE and about 38 other injectables marketed by Phyne was enacted by AMRAM in December due to concerns of substandard manufacturing conditions found by FDA officials on a visit to AMRAM’s facilities. However, the FDA believes that Phyne delayed taking action to remove the recalled products from the market, and the agency last week issued a warning to healthcare organizations and medical product distributors that AMRAM and Phyne’s products may be unsafe. Phyne has now informed the FDA that it will not include ACE in the recall effort, according to the agency’s statement on Monday. “FDA shares the same safety concern about ACE as it does with the products which Phyne Pharmaceuticals is recalling because all of the products were manufactured by AMRAM Inc. under the same conditions violating good manufacturing standards for pharmaceuticals,” the agency said. Phyne was not immediately available for comment. In interviews with Reuters Health last week, company representatives argued that it was the FDA that had held up the recall and that the products at issue are not actually defective.

Conflict of Interest and the Public Trust – (11-29-00)

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Conflict of Interest and the Public Trust

This is a very interesting commentary on the impact that the pharmaceutical companies have on physician decision making. This “conditioning” by the pharmaceuticals begins as the physicians are students. Unfortunately, this relationship leads to clouded judgement and future education built mainly on what the drug companies provide.

Read entire article here

Up to 5% of Clinical Trials May Be Fraudulent – (01-24-02)

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Up to 5% of Clinical Trials May Be Fraudulent

Now doesn’t this make things a little scary? Articles like this do put things into perspective in two ways. First, money always talks. If you have the money there’s a good chance you can get the results you want. Second, this shows that that mainstream medicine has no right throwing stones at natural medicine. While many concepts and therapies in natural medicine do not have the clinical trials behind them, they do, in some cases, have literally hundreds of years of anecdotal evidence and safety profiles to put against the clinical trial.

News Release: At least 1%, and possibly as many as 5%, of drug trials are compromised by fraudulent data, a British pharmaceutical fraud investigator said on Tuesday. Dr. Frank Wells, director of Medico Legal Investigations Ltd, urged countries to set up new disciplinary bodies to ensure doctors found guilty of research fraud are struck off the medical register. “The incidence of clinical research fraud is difficult to assess but my own estimate is that it is at least 1% and possibly much higher,” he told the Society of Biomedical Research in London. “If we estimate that there are about 3000 sponsored clinical research projects taking place within the UK at any one time, this means that at least 30 will include investigators who are generating false data.” Dr. Wells, who has investigated cases of suspected fraud for the past 10 years, said some doctors become clinical investigators out of greed, vanity, arrogance, boredom and the pressure to publish scientific papers. Examples of fraud include a surgeon who claimed to have assessed a patient 6 months after the patient had died and a doctor who claimed to be assessing blood flow in the leg of a patient that had been amputated. Another doctor had forged 191 patient signatures and other data in 21 studies. Dr. Wells told the meeting on fraud and misconduct in biomedical research that in Britain doctors faced the deterrent of being reported to the General Medical Council’s disciplinary body which can strike doctors off the medical register for serious professional misconduct. But similar sanctions do not yet exist in many other countries. In the United States, the maximum penalty under Food and Drug Administration rules is to be barred from using federal research funds for 3 years. In France, silence is generally the golden rule on fraud though it is hoped that action would eventually be taken at the EU level, he continued. In Germany, rules about misconduct in science were only introduced a couple of years ago. In Italy and Spain, there are no antifraud measures worth reporting, Dr. Wells claimed. American pharmaceutical consultant Arthur Horowitz said complaints filed with the FDA against investigators had increased from 11 in 1992 to 118 in 2000. Thirty-five percent of complaints involve protocol violations and 24% involve falsification of data. Another area of concern is the huge expansion of clinical trials in eastern Europe, Africa and South America where ethical review boards are often inexperienced.