[Journal article]Pollution from drug manufacturing: review and perspectives

Pollution from drug manufacturing: review and perspectives.

From the article at Philosophical Society of the Royal Society

As long ago as the sixteenth century, Paracelsus recognized that ‘the dose makes the poison’. Indeed, environmental concentrations of pharmaceuticals excreted by humans are limited, most importantly because a defined dose is given to just a fraction of the population. By contrast, recent studies have identified direct emission from drug manufacturing as a source of much higher environmental discharges that, in some cases, greatly exceed toxic threshold concentrations. Because production is concentrated in specific locations, the risks are not linked to usage patterns. Furthermore, as the drugs are not consumed, metabolism in the human body does not reduce concentrations. The environmental risks associated with manufacturing therefore comprise a different, wider set of pharmaceuticals compared with those associated with risks from excretion. Although pollution from manufacturing is less widespread, discharges that promote the development of drug-resistant microorganisms can still have global consequences. Risk management also differs between production and excretion in terms of accountability, incentive creation, legal opportunities, substitution possibilities and costs. Herein, I review studies about industrial emissions of pharmaceuticals and the effects associated with exposure to such effluents. I contrast environmental pollution due to manufacturing with that due to excretion in terms of their risks and management and highlight some recent initiatives.

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Celebrity endorsements of prescription drugs

From the 7 July 2011 KevinMD column by Richard Meyer

Boniva continues to use Sally Field as a celebrity spokesperson for their product but as John Mack pointed out, should any prescription drugs be paying celebrities to endorse their products?  Well, according to an Ace Metrix study the answer to that is “probably no.”

The Ace Metrix study found of more than 2,600 ads that celebrity ads do not perform any better than non-celebrity ads and in some case perform much worse.  In their study whether or not a celebrity endorses a product was unimportant in determining whether an ad resonated with viewers.  In fact compared with industry norms relatively few celebrity ads were able to earn performance marks above the industry averages…

Read entire article

Drug regulators are protecting profits over patients, warn researchers

From a 10 May Science Daily article

ScienceDaily (May 10, 2011) — Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers on the British Medical Journal website.

They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.
Despite the existence of hundreds of thousands of clinical trials, doctors are unable to choose the best treatments for their patients because research results are being reported selectively, write Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark.
Selective reporting can have disastrous consequences. For example, Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s…..

…Journal Reference:
P. C. Gotzsche, A. W. Jorgensen. Opening up data at the European Medicines Agency. BMJ, 2011; 342 (may10 1): d2686 DOI: 10.1136/bmj.d2686 [Links to the free full text of the article]

Click here to read the rest of the Science Daily article

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Off-Label Promotion Analyzed, Fixes Involve Docs

From the April 6 2011 MedPage Today article

By Cole Petrochko, Staff Writer, MedPage Today

Healthcare professionals are the best defense against illegal off-label*** marketing of drugs, researchers found. “Our findings suggest that no regulatory strategy will be complete and effective without physicians themselves serving as a bulwark against off-label promotion,” Aaron S. Kesselheim, MD, MPH, of Harvard, and colleagues wrote in the April issue of PLoS Medicine. Despite regulations against off-label marketing, the practice appears to have fluorished in the last several years, the researchers noted. To get a better understanding of the problem, they analyzed whistleblower-initiated legal complaints filed in off-label marketing cases over the last 15 years…. … Prescriber-related practice complaints included: Encouraging healthcare professionals to prescribe for off-label use through false or unbalanced study data (76% of all prescriber-related practice complaints) Distributing free samples as a convenient source of off-label promotion (20%) Providing “lavish gifts” or honoraria to healthcare professionals (85%) Creating CME activity with speakers known to promote off-label use or through shell corporations (54%) Payer-related practice complaints included: Discussions with prescribers to ensure insurance reimbursement for off-label prescriptions (78% of all payer-related practice complaints) Discussions with payers to ensure insurance reimbursement for off-label prescriptions (35%) Advice on ways to bypass an insurer’s restrictions on a drug’s prescription (53%) Falsification of billing codes (48%)   ***Off-label use: In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved medications for other than their intended indications. This practice is known as off-label use [MedicineNet.com definition]

 

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‘Dispense as written’ prescriptions may add $7.7 billion to annual health care costs in U.S.

‘Dispense as written’ prescriptions may add $7.7 billion to annual health care costs in U.S.

From the March 25 2011 Science Daily news item

ScienceDaily (Mar. 25, 2011) — Approximately five percent of prescriptions submitted by CVS Caremark Pharmacy Benefit Management (PBM) members in a 30-day period during 2009 included a “dispense as written” (DAW) designation. This practice — whereby doctors or patients demand the dispensing of a specific brand-name drug and not a generic alternative — costs the health care system up to $7.7 billion annually, according to a new study by researchers at Harvard University, Brigham and Women’s Hospital and CVS Caremark. Moreover, these requests reduce the likelihood that patients actually fill new prescriptions for essential chronic conditions.

In a study published this week in the American Journal of Medicine,*** the researchers demonstrate that DAW designations for prescriptions have important implications for medication adherence. They found that when starting new essential therapy, chronically ill patients with DAW prescriptions were 50 to 60 percent less likely to actually fill the more expensive brand name prescriptions than generics. “Although dispense as written requests would seem to reflect a conscious decision by patients or their physicians to use a specific agent, the increased cost sharing that results for the patient may decrease the likelihood that patients actually fill their prescriptions,” the researchers said……

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Many get antidepressants for no psychiatric reason

Many get antidepressants for no psychiatric reason

From the February 4, 2011 Health Day news article by Frederik Joelving

NEW YORK (Reuters Health) – More than a quarter of Americans taking antidepressants have never been diagnosed with any of the conditions the drugs are typically used to treat, according to new research.

That means millions could be exposed to side effects from the medicines without proven health benefits, researchers say.

“We cannot be sure that the risks and side effects of antidepressants are worth the benefit of taking them for people who do not meet criteria for major depression,” said Jina Pagura, a psychologist and currently a medical student at the University of Manitoba in Canada, who worked on the study.

“These individuals are likely approaching their physicians with concerns that may be related to depression, and could include symptoms like trouble sleeping, poor mood, difficulties in relationships, etc.,” she added in an e-mail to Reuters Health. “Although an antidepressant might help with these issues, the problems may also go away on their own with time, or might be more amenable to counseling or psychotherapy.”

The researchers tapped into data from the Collaborative Psychiatric Epidemiologic Surveys, which include a nationally representative sample of more than 20,000 U.S. adults interviewed between 2001 and 2003.

Roughly one in ten people told interviewers they had been taking antidepressants during the past year. Yet a quarter of those people had never been diagnosed with any of the conditions that doctors usually treat with the medication, such as major depression and anxiety disorder.

According to The National Institute of Mental Health, nearly 15 million American adults suffer from major depression, and 40 million more have anxiety disorders.

Although the survey didn’t include all mental illnesses that might have led doctors to prescribe an antidepressant — say, obsessive-compulsive disorder or to help quit smoking — other experts said the new findings are not exaggerated.

“Reviews of claims records, which are diagnoses actually given by health care professionals, suggest that only about 50% of patients who are prescribed antidepressants receive a psychiatric diagnosis,” said Dr. Mark Olfson, a psychiatrist at Columbia University in New York.

“These findings raise questions about the clinical appropriateness of antidepressant treatment selection for many primary care patients,” he added in an e-mail to Reuters Health.

With sales of $9.9 billion in 2009, up three percent since the previous year, antidepressants rank fourth among prescription drugs in the U.S., according to IMS Health, a company that analyzes the pharmaceutical industry.

Popular brand names include Pfizer’s Zoloft, Forest Laboratories’ Lexapro and Eli Lilly’s Prozac.

While studies have shown the drugs may help some people with depression, they come with a price tag — and not only the $100 or more that a month’s supply can cost. Some users experience sexual problems or gain weight, for instance.

“Nearly all medication has side effects, so there are undoubtedly a large number of Americans who are taking antidepressants that may not be effective at treating their conditions, yet they suffer from the side effects,” said Jeffrey S. Harman, an expert in health services at the University of Florida in Gainesville, who was not involved in the new study.

“Not to mention inappropriate use of our health care dollars that comes along with inappropriate prescribing,” he added in an e-mail.

Still, Harman said the findings, published in the Journal of Clinical Psychiatry***, didn’t necessarily mean doctors are prescribing more antidepressants than they should.

“As far as overprescribing, I don’t think you can say that it is occurring as a blanket statement,” he explained. “There are undoubtedly many people being prescribed antidepressants that may not be effective for them, but there are also millions of Americans suffering from depression who are not being prescribed antidepressants or are being prescribed them at a suboptimal dose.”

Pfizer did not comment directly on the new findings, but told Reuters Health it was dedicated to ensuring “that patients and their doctors have the most up to date medical information on which to base their treatment decisions.”

SOURCE: http://bit.ly/eXPVSL*** Journal of Clinical Psychiatry, online January 25, 2011.

 

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Tipping points — the future of the pharmaceutical industry

Tipping points — the future of the pharmaceutical industry

From the February 4, 2011 Eureka news alert

This declining trend is blamed on a failure of innovative drive in the industry, failure of the UK to support basic research, failure of venture capital to invest in early stage research, or failure of the Health Service to provide smart procurement.

A research centre funded by the Economic and Social Research Council (ESRC) shows that radical reform of the drugs industry regulatory system must be an important part of the solution to ensure a productive and profitable pharmaceutical sector, both globally and in the UK.

Researchers from the ESRC’s Innogen centre have studied the innovation models in the pharmaceutical industry and how the industry has been able to remain sustainable for so long. The results of their research show that the lengthy and expensive regulatory system that now applies to most products of the life sciences is causing innovation failure.

Regulation has a large impact on the kinds of product that are developed by any industry sector: it is designed to ensure that products are safe, effective and of high quality. Innogen’s research demonstrates that the impacts of regulation in pharmaceuticals are more far-reaching: they determine overall company strategies; which types of companies succeed; and ultimately the structure and dynamism of the sector as a whole. Under current circumstances regulation prevents the development of the radically innovative technologies that could provide opportunities for the sector to become more effective in developing innovative products. Innogen research has predicted that the industry is approaching a tipping point in the not too distant future.

Professor Joyce Tait comments “We do not need less regulation, but smarter regulation, that can deliver expected standards of safety and efficacy, are flexible enough to respond to new scientific discoveries and can do so more efficiently than our current systems within a shorter time frame.”

Innogen research also shows that policymakers and governments need an understanding of all the major causes and relevant options available. Radical regulatory reform for the life science industries needs to be a priority in discussions regarding the future of the industry. Reform could provide the lever to profitably unleash the creativity that has been so effectively generated from public funding of basic science, leading to something closer to the innovative performance that we have seen in information and communication technologies over the past twenty years.

 

How do data exclusivity periods affect pharmaceutical innovation?

How do data exclusivity periods affect pharmaceutical innovation?

Study is first to estimate financial and social impact of extending exclusive access to clinical trial data for conventional drugs

From a January 6, 2011 Eureka news alert

LOS ANGELES, Calif. — January 6, 2011 — Pharmaceutical companies and generic drug manufacturers have long been at odds over regulations about “data exclusivity,” the period of time before generic manufacturers can make use of valuable clinical trial data.

A new study in the January 2011 issue of Health Affairs *** is the first to calculate the financial and social costs of limiting access to trial data — and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

“Elected officials are unlikely to embrace legislation that would result in higher drug prices, but our research suggests that legislation to extend data exclusivity would spur innovation that would benefit future generations,” explained Dana Goldman, lead author, director of the Schaeffer Center for Health Policy and Economics at USC and Norman Topping Chair in Medicine and Public Policy at USC.

The pharmaceutical companies that introduce new drugs are currently granted five years of exclusive access to the clinical trial data they submit during the approval process. An extension of three years is available if new applications arise and a six month extension is granted if the drug is approved for use in pediatric populations.

In 2007, the National Academies Committee on Science, Engineering and Public Policy called for extending this “data exclusivity” term to the longer period used in Europe, ten to 11 years. But generic manufacturers have argued for shorter limits so that they can bring less expensive versions of drugs to patients sooner.

“Unfortunately, the health policy literature contains no information about the effects such a policy would have on innovation, population longevity and social welfare,” said Darius Lakdawalla, research director at the Schaeffer Center at USC and associate professor in the USC School of Policy, Planning and Development.

In the first study to directly address these issues, the researchers estimate that extending the term of data exclusivity to 12 years would increase the lifetime revenue of a drug by 5 percent, on average.

With empirical evidence that profits drive drug innovation, this longer term would lead to an additional 228 drug approvals over the next fifty years and an increase of 1.7 months in average life expectancy, according to the study.

John Romley, an economist with the Schaeffer Center at USC and research assistant professor at the USC School of Policy, Planning and Development, acknowledged the trade-off between current and future generations: “Americans in the early 2020’s would bear the cost of increasing drug spending. However, people turning 55 in 2060 could expect increased life expectancy as a result of innovation in the interceding years — that is, new drugs brought to market because of lengthier data exclusivity.”

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