Eve—Can a Robot Replace a Scientis

•May 27, 2009 • Leave a Comment

I recently came across article touting about a “Robot Scientist” Eve that can make informed guesses about how effective different chemical compounds will be at fighting different diseases. Eve use advanced artificial intelligence in combination with innovative data mining and knowledge discovery techniques, to analyze the results of pharmacological experiments that it performs itself.

As we know with the emergence of the human genome, new frontiers in drug discovery process have opened, ameliorating our understanding and identification skills of more ‘molecular targets’ responsible for various diseases. 

Currently, when a new drug is sought, pharmacological researchers conduct a blind study of hundreds of thousands of chemical compounds, applying them to an assay for a disease. The results of those tests determine the so-called Quantitative Structure-Activity Relationships (QSARs) that relate the structure of a chemical compound to its pharmacological activity. Exhaustive testing like this is time-consuming, costly and generally has to be repeated each time a new drug is sought.

According to Dr. Dzeroski, Eve is the first computer system capable of originating its own experiments, physically performing them, interpreting the results and then repeating the cycle, resulting in minimizing the need for random testing of chemical compounds.

Unlike most data mining approaches, in which an individual analysis is carried out on a single dataset, such as a spreadsheet, Eve utilizes the techniques that  allow knowledge discovery processes, consisting of several analysis steps, to be carried out across multiple sets of complex data.

It has been decided that Eve will initially put to work at the University of Wales to search compounds for treatment of malaria and schistosomiasis, so-called Third World diseases that are the focus of only limited research by commercial drug companies.

No doubt science and technology, if goes hand in hand, can create wonder. Eve can bestow scientists a revolutionary tool to develop effective treatments in a cost and time saving manner, However, the question arises, are we prudent enough to use such technology?

Think about it.

Until next time,

Good Luck.

Academic Research- Can it be trusted.

•March 21, 2009 • Leave a Comment

The health community seems to be watching some fireworks this years- big merger, layoffs, patent expiration. And latest addition to this is the recent news that alarmed the scientific community- Dr. Scott Reuben, a highly-respected and influential clinical researcher, fabricated the data used in over twenty pharmaceutical studies published in peer-reviewed medical journals.

Published between 1996 and 2008, his studies backed painkillers Bextra (Pfizer) and Vioxx (Merck), as well as other drugs such as Pfizer’s Celebrex and Wyeth’s Effexor XR. It is interesting to note that part of the research cost for these studies was paid by companies like Pfizer and Merck, indicating the financial ties between the research study and two companies that are most benefitted by these studies.

According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Reuben’s “research”, it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements, the Journal said.

Note carefully the names of the medical journals that published Dr. Reuben’s fabricated data. These so-called “science journals” claim to be peer-reviewed, which means these studies were approved by multiple scientists who agreed with the findings.

What this scandal reveals is that even peer-reviewed medical journals cannot be trusted to publish truthful, accurate information about pharmaceuticals. 

According to David Shaywitz, “University researchers are in a constant battle for recognition and the rewards associated with success: research space, speaking engagements, funding and autonomy. Consequently, while academic research is often described as “curiosity-driven,” the reality is messier, as (curiously) many researchers tend to pursue the trendiest technologies and explore topics that happen to be associated with the most generous levels of research support”.

Science as it is practiced today relies on a fair measure of trust. Part of the reason is that the culture of science values openness, hypothesis testing, and vigorous debate.  However the incentive to generate positive results to a hypothesis is mostly so high that it motivates investigators, though sometime, to disregard contradictory observations, to overvalue data that might be preliminary or unreliable, and to embrace conclusion that bring more recognition.

Such incidences only invoke a more responsible and prudent behavior from all the members of scientific community so that we can avoid such scientific frauds in future. 

Ranbaxy got to fix this

•March 1, 2009 • 1 Comment

With the growing popularity of generic drugs and a number of major branded drugs losing patent protection in coming years, Daiichi Sankyo’s deal last year with generic maker Ranbaxy seemed pretty logical. But Ranbaxy has run into host problems since then — the latest of which came few days back, when the FDA accused the company of “Falsifying data”.

The Agency “has determined that [Ranbaxy] submitted untrue statements of material fact in abbreviated and new drug applications filed with the Agency. ….from the Ranbaxy Laboratories Limited site located at Paonta Sahib, Himachal Pradesh, India.”

FDA has decided to invoke its AIP (Application Integrity Policy) against Ranbaxy. AIP procedure is undertaken when company’s actions raise significant questions about the integrity of data in marketing applications. 

According to The Wall Street Journal, most of the misled data was to prove drugs are stable over a certain time period.  The problems were discovered during a 2006 inspection, and included drug samples meant for required stability testing stored in refrigerators, even though the samples should have been stored at room temperature.

Earlier in September 2008, the FDA had issued two warning letters and imposed an import ban on 30 different Ranbaxy drugs because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at Paonta Sahib.  However, three drugs tested at the Paonta Sahib plant are still in U.S. circulation because they are manufactured at the company’s New Jersey plant. Those drugs are a generic decongestant and generic versions of Merck & Co. Inc.’s Zocor and Bristol-Myers Squibb’s Pravachol. Both are widely used cholesterol drugs.

 In addition, Ranbaxy has been under investigation by FDA and the Department of Justice, and has been scrutinized by Congress.  It has been reported that Ranbaxy’s troubles with FDA were one of the factor that led to the introduction of the 2008 FDA Globalization Act (FDAGA).

With U.S pharmaceutical industry struggling with patent expirations, Indian generic companies seemed all set to grab this opportunity. However Ranbaxy issue has raised questions about whether India is ready to play an expanded role in sensitive areas such as early-stage clinical trials and whether its manufacturing standards are up to international levels.

 

Until next time…

Good luck.

 

Pfizer Wyeth deal: Acquisition Mania or Prudent Decision.

•February 24, 2009 • 1 Comment

The news of the $68 billion acquisition deal between Pfizer and Wyeth didn’t surprise me much. It is one of the expected desperate attempts by Pfizer to overcome from the forecasted loss of $13 billion revenue per year, when Lipitor will get off patent in November 2011.  The merger is being touted as an “ideal marriage”, with the potential to save billions for both companies. It would also diversify Pfizer into the area vaccines and injectable biologic medicines by adding Wyeth’s big-selling Prevnar vaccine for childhood infections and Enbrel for rheumatoid arthritis treatment.

 But the deal also raises questions about whether another huge acquisition is the right antidote for Pfizer, which has struggled after digesting two huge deals in the past decade (Buying Warner –Lambert in 2000 and swallowing Pharmacia-Upjohn in 2003, posted Pfizer with serious alignment and integration issues). And it threatens to spark another round of layoffs in the drug industry at a time the U.S. economy is already on its knees.

The Irony starts here. The deal is being financed by five banks: Bank of America Merrill Lynch, Barclays, Citigroup, Goldman Sachs and J.P. Morgan Chase. The billions that will be lent to Pfizer are coming from the Troubled Asset Relief Program (TARP) program that the US government initiated to ameliorate the depressive economy. This was done to unfreeze credit markets and to purportedly provide relief, albeit indirectly, to American taxpayers many of whom are in financial trouble. That’s right. Money involved in this deal is coming from taxpayer’s pockets! And what are they getting in returns, more job cuts! (Pfizer publicly acknowledges that the combined company will shed 19,500 jobs).

It is also interesting to note Pfizer currently has six Alzheimer drugs under development and one on the market, while Wyeth has four of Elan’s Alzheimer drugs and five Alzheimer drugs of its own in development. Pfizer will now control 16 Alzheimer drugs, which represents a majority of all Alzheimer drugs currently in clinical development and on the market, creating a virtual monopoly for itself.

As a result, Pfizer will likely favor those drugs in which it holds more revenue profits. Ultimately, the biggest loser in this situation would be Alzheimer patients, along with their caregivers and physicians, who may have fewer treatment options available to them.

It would be interesting to see how the acquisition turns out to be for Pfizer, but observing the current situation I find no one getting any smiles – not the stockholders, not the employees, not the consumer/common taxpayer’s and definitely not drug development process.

Until next time…

Good luck.

 

 

 

Surge in New Drug Approval in 2008

•February 23, 2009 • Leave a Comment

 

Going against all odds, FDA in 2008 approved 24 new drugs, after a nearly dry year of 2007 where FDA approved 18 new drugs, fewest in 24 years. New drugs approved in 2008 include cancer treatment Treanda from Cephalon, antidepressant Pristiq from Wyeth, and low-platelet count therapies Promacta and Nplate from GlaxoSmithKline and Amgen. These new substance approvals come in addition to dozens of reformulation and expanded-application approvals. 

The increase in new drug approval in 2008 has lead me to two interpretations- FDA with all the blames and criticisms over their head, finally decide to lax there standards or  pharma companies are prudently submitting more relevant and efficient drug therapeutic/safety data’s (or might be taking less risky candidates for approval). Whatever might be the reason; this increase in new drug approval seems to be “consolation of sorts to an industry struggling with greater scrutiny, thousands of layoffs and thinning drug pipelines.” (Wall Street Journal).

However it is interesting to note that despite this ‘unusual’ increase in approvals, FDA to an extent had not sufficiently lived up to their own expectation. FDA sets a goal of reaching a final decision on 90% of applications within the six- to ten month time frame. However, FDA said it missed deadlines on 32 out of 159 drug applications making it to around 20%, through Oct. 31, 2008. John Jenkins, the director of FDA’s office of new drugs, himself confirmed that the agency is “struggling to meet drug approval goals for the past several years”.

The FDA has been granted funding to improve its approval processes, including the hiring of new employees, but the anticipated improvement will likely take some time to come into play. Hope the situation change sometime soon as the “Patients are still waiting for their treatment”.