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People In Life Sciences P.I.L.S. HomeCompliance Column
The good, the bad and the ugly
May 26, 2005
Fiona Jones
Compliance Columnist
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Throughout the late 1980s and early 1990s, the public was very excited about the growing pharmaceutical industry with expectations of innovative drugs becoming available to cure every ill. It now seems as if pharmaceutical companies have lost all support and are labeled as the latest bad boys of industry. Even a quick glance at the news gives the impression of a lack of industry oversight and prompts rumors of drug side effects being brushed under the carpet to maintain healthy company profits. Is this a fair judgment? If so, then what are we doing in the compliance sector to correct these problems? Every day, throughout the world, every pharmaceutical and biotechnology company has staff eagerly working away to develop systems and procedures to introduce, maintain, and ensure strict compliance with regulatory agency guidelines and yet every day the news appears to run a story highlighting an error in the system. Is the coordination of introducing and monitoring quality in the pharmaceutical industry failing or is it just a case that the failures are more newsworthy than the successes?

I challenge you to enter “pharmaceutical” or “drug company” or any combination of similar words in to the news search engine of your choice and take a look at the results. I think you will see that there is a lot more happening in our industry than scandal and controversy. Below is a short summary of some of the news items – good, bad and ugly - that I pulled up.

The good

IBM Healthcare & Life Sciences has announced an initiative to support the pharmaceutical industry’s drive towards operational excellence, quality by design and risk-based compliance. IBM has teamed with leading technology providers to develop a solution aimed at enabling the transformation of pharmaceutical development and manufacturing capabilities of large pharmaceutical and biotechechnology companies. The company has developed a Proof of Concept (PoC) that demonstrates how the Food and Drug Administration’s (FDA) Science of Design and Manufacturing Science concepts can be enabled in a Service Oriented Architecture. IBM forecasts that by managing risk and applying scientific- and systems-based approaches throughout development and manufacturing, the top 30 pharmaceutical companies alone can protect up to $60 billion of future revenues, accelerate time to peak sales by two years or more, and reduce Cost of Goods Sold (COGS) by up to 16%. That must be good news.

In the area of clinical trials Genentech, Inc. announced that their phase III clinical study of Lucentis(TM) (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration (AMD). Approximately 95 percent of patients maintained or improved vision at one year when treated with Lucentis(TM) injections compared to approximately 62 percent of those treated in the control arm (p<0.0001).

Alkermes Inc. has also announced positive results from a phase III, open-label, 12-month extension study of Vivitrex(R) (naltrexone long-acting injection) in alcohol-dependent patients. Findings from the study showed that Vivitrex(R) and counseling led to a sustained reduction in heavy drinking over an 18-month treatment period among patients who had completed the six-month Phase III efficacy trial ("main trial") and enrolled in an open-label 12-month extension study. Over eighty-five percent of patients who completed the main trial chose to participate in the extension study.

At the beginning of the month, Biovail Corporation announced that it has received an Approval Letter from the FDA for Tramadol ODT (tramadol hydrochloride), an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride in 50mg dosage format, intended for the treatment of moderate to moderately severe pain in adults.

Alpharma Inc. also received approvable status on that its pending application for Kadian(R) 200mg a sustained release morphine sulfate product.

Boehringer Ingelheim Pharmaceuticals, Inc. was also the bearer of good news when they announced that the FDA Antiviral Drugs Advisory Committee recommended the approval of the investigational anti-HIV drug tipranavir.

So while the good news is there for those who look, it is perhaps not as exciting to the mainstream news media as some of the more scandalous events in our industry. Certainly, you can see why editors are not running these items on the front page of your local newspaper.

The bad

Unfortunately, the bad news items are around and are getting a lot of press. Able Laboratories, a small New Jersey-based generic drug manufacturer, was once a fast-growing star of the highly competitive $18billion generic drug industry. Then, on May 23, the company announced it was shutting down operations and ordered a nationwide recall of its products. The company, which employed 421 full-time employees, had an extensive range of 46 medications including prescription generic versions of Ritalin, Tylenol and Vicodin. So what went wrong? Able stated that the dramatic actions stemmed from an internal review of operating practices, which began after product recalls earlier in the year. Problems were apparently identified when working with outside consultants and the FDA. The company said in a statement the shutdown was prompted by "apparent departures from standard ... laboratory testing practices" and that the operations would halt "until such time as it can assure itself that its products are manufactured and tested in compliance with standard operating procedures and current good manufacturing practices." However, it appears that there has been a history of manufacturing problems dating back to 1992. The company signed a federal consent decree that called for a $450,000 fine, FDA supervision of its manufacturing facility and the forced resignation of two company executives. The court supervision ended in February 2002, but it doesn’t appear that the problems did. Last year the company received an FDA warning letter for failing to report serious side effects of some of its drugs. The letter stated:

“The specific violations noted in this letter are serious and may be symptomatic of serious underlying problems. You are responsible for investigating and determining the causes of the violations identified above and preventing recurrence of similar violations. You should take prompt action to correct these deficiencies. Failure to promptly correct these deviations may result in regulatory action without further notice. These actions may include, but are not limited to, seizure of your products and/or injunction. Federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.”

It appears that the FDA’s concerns over “serious underlying problems” were well-founded. The series of events has thrown the immediate future of the company into doubt and it is exactly the news story that will have a ripple effect on the rest of the industry. With the FDA keeping a watchful eye on the company and the stringent procedures that are supposedly in place to protect the public health it seems inconceivable that so many problems can be coming out from just one company.

The ugly

Medical journalists are increasingly making their thoughts known regarding the pharmaceutical industry and transparency in clinical trial data is certainly one topic that seems to get editors hot under the collar.

Last week, Richard Smith, former editor of the British Medical Journal (BMJ) voiced his concerns about the power and influence of the industry and claimed that medical journals are nothing more than extensions of the marketing arm of pharmaceutical companies. Strong words, but are his comments justified? Smith, now chief executive of UnitedHealth Europe, published his forthright essay in the open access international health journal PloS Medicine. Smith is not alone in his condemnation of the industry. Last year Richard Horton, editor of the Lancet, wrote that "Journals have devolved into information laundering operations for the pharmaceutical industry" and Marcia Angell, former editor of the New England Journal of Medicine, also damned the industry for becoming "a marketing machine".

In his recent article, Richard Smith went as far as to suggest that the pharmaceutical industry employs a series of tricks to ensure good publicity for new products in prestigious journals. He said it was often impossible for editors to spot a rigged trial, despite the process of peer review and highlighted a "conflict of interest" because publishing trials by major drug companies would result in increased sales.

The Association of the British Pharmaceutical Industry was quick to deny the allegations, saying it would make no sense to manipulate trials because they would eventually be discovered. "There’s no future in twisting trials’ results because you’ll get found out long before you get to market, and with the costs of lawsuits and so on, it’s just not worth getting it wrong."

This month, the editor in chief of the New England Journal of Medicine accused three of the largest drug companies of "making a mockery" of efforts to create transparency in clinical trials. Editor, Jeffrey Drazen, said that Pfizer, GlaxoSmithKline and Merck are not providing enough useful information on clinical trials they register with the government. His comments were based on a review of the information drug companies posted on www.clinicaltrials.gov, which is run by the U.S. National Institutes of Health.

The errant underdog

So while the good news items are out there, they are perhaps not as interesting to the general public as the stories of rigged trials, over-priced drugs, deliberately withholding negative trial data, dodgy drug companies and counterfeit drugs flooding the market from overseas. As to whether all publicity really is good publicity? Luckily, the public always loves a good comeback story, and is usually willing to give an errant underdog a second chance if the problems have been handled correctly. So hopefully for the pharmaceutical industry, we will all get a second chance and in turn a media bonanza!


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