Thursday, October 20, 2016

Taking Ayurveda global: Thoughts on BGR-34, and what we can learn from the Chinese example

A few months ago, India's Council for Scientific and Industrial Research (CSIR) announced the launch of a new, government-approved Ayurvedic anti-diabetic drug, BGR-34. Scientists claimed that the drug - composed of half-a-dozen herbal extracts identified after an extensive search of herbs listed in ancient Ayurvedic texts - was able to manage blood sugar effectively without any of the side effects associated with standard anti-diabetic medications.

It was jointly developed by two Lucknow-based CSIR institutes, the National Botanical Research Institute (NBRI) and the Central Institute for Medicinal and Aromatic Plants (CIMAP). A third entity, a private company by the name of AIMIL Pharmaceutical, was appointed to be the commercial producer and distributor of BGR-34. Supposedly, AIMIL conducted clinical trials of BGR-34 in which the drug exhibited hypoglycemic activity. NBRI's principal scientist also claimed that the drug had no side effects. Surprisingly, there is no evidence available to support these and other claims of BGR-34's accuracy: no peer-reviewed papers, no clinical trial registry, no data of any kind. Basically, we have a bunch of people telling us (through press conferences and advertisements, no less) that BGR-34 works really well as an anti-diabetic agent, without presenting any evidence at all to buttress their claims.

Naturally, India's scientific establishment went up in arms. Prominent scientists pointed out that in the absence of proper validation, it was unethical for a government body (CSIR) to promote the drug, thereby tarnishing its own reputation as well as casting a shadow on the public perception of Ayurveda (here's a detailed exposition of why this is the case). 

Wednesday, October 12, 2016

If it's not one thing, it's another: the latest on Theranos

I recently posted about the troubles surrounding Theranos, the much-hyped blood diagnostics company. Well, since that post, things have gotten even worse for the company and its beleaguered founder, Elizabeth Holmes. First, it withdrew from the direct-to-consumer blood testing business, shutting down its blood-testing facilities and laying off nearly 40% of its workforce. Instead, it planned to focus on its newly-introduced miniLab device (which when unveiled in August met with its fair share of scepticism).

One week after this announcement comes the news that a major investor, Partner Fund Management LP, is now suing Theranos, alleging that the company engaged in securities fraud and other fraudulent acts to attract investment. Partner Fund, which had invested nearly $100 million in Theranos, claims that both Holmes and former company president Sunny Balwani lied about the company's scientific capabilities, specifically about its flagship Edison testing platform.

Friday, October 7, 2016

2016's Nobel Prize for Medicine

The 2016 Nobel Prize for Medicine has been awarded to Yoshinori Ohsumi, the Japanese scientist who used a yeast model to study and extensively characterize autophagy, the process by which cells recycle and degrade damaged components (here's a simple explanation of what autophagy is, and why it's important).

Monday, September 26, 2016

Quick links

Here are links to some interesting stories around the web:

  • The fall of Theranos, the much-hyped diagnostics company looking to revolutionize the field of blood testing, has been making headlines. This is a closer look at what exactly went wrong with Theranos and its charismatic founder, Elizabeth Holmes, following up on the heels of a detailed investigation published by the Wall Street Journal. Once the subject of glowing profiles that sounded like every Silicon Valley cliché come to life (her habit of drinking green smoothies containing kale and her fluency at Mandarin among the highlights), Holmes found herself going from being America's richest self-made woman (as per Forbes) to having her estimated net worth revised to zero. As it stands, she is now banned from participating in the blood-testing industry for two years and the company is in very deep waters.
  • Making the point that promising scientific discoveries do not necessarily translate to blockbuster drugs, Science looks at six molecules - nitric oxide, hydrogen sulfide, leptin, ghrelin, myostatin and sirtuins - where the biology has turned out to be far more complex than the hype would lead us to believe.
  • Here's a profile of Mitra Biotech, an Indian startup with a pioneering personalized medicine model that oncologists can use to tailor therapeutic regimens for individual patients.
  • The newly-announced Chan-Zuckerberg Initiative has dedicated $3 billion to preventing, curing and eliminating disease by the turn of the century.
  • And in sadly unsurprising news, the patent battle around the revolutionary CRISPR-Cas9 gene editing techniques gets uglier and more complicated.

Monday, October 26, 2015

Rebooting India, now on Amazon

Slightly off-topic, but Rebooting India: Realizing a Billion Aspirations (by Nandan Nilekani and Viral Shah) is now up for pre-order on Amazon. I carried out the research for this book, and helped with the writing and editing as well. I may be biased, but I think this book offers an excellent perspective on how technology can be used to radically re-imagine government, as well as how technology can be used to address some of the biggest challenges that India faces (which, by the way, includes an entire chapter on Indian healthcare). Do take a look and share your thoughts!

Monday, October 12, 2015

Updates on the GVK story

Earlier this year, I'd posted some quick links about GVK Biosciences, a Hyderabad-based clinical research organization which was accused of falsifying clinical trial data on a massive scale, ultimately leading to 700 generic drugs tested by GVK being banned in the European Union pending further investigation.

Since then, the story has gotten murkier. First, this investigative report claims that the entire situation was precipitated by an affair between two employees, a married executive and his subordinate. The two eloped, the police were called in, and as they searched the executive's email, found that he had sent emails "to every major drug regulatory authority in the world raising doubts about the quality of clinical research conducted at GVK Biosciences."

Sunday, January 25, 2015

Quick links

From around the web:

  • More on data manipulation - Allegations against Hyderabad-based GVK Bio regarding manipulated data in clinical trials of generic drugs conducted on behalf of European drugmakers might result in over 100 medicines being pulled from the market. Updated to add: Here's a link to another discussion on the subject.
  • Patent issues - The Indian patent office has refused to grant US company Gilead a patent for its blockbuster hepatitis C drug Sovaldi on the grounds that the "molecules and compounds of the drug are known elements". Although Gilead had previously granted voluntary licences to Indian companies to manufacture the drug at a lower cost, it still remains out of reach for the poor with a pricetag of 55,000 rupees for a 12-week course. Those backing the production of low-cost, generic versions of drugs to benefit the poor have hailed this decision while experts in intellectual property issues have questioned the validity of the court's judgement.
  • FDA issues - Generic drug company Ipca Laboratories has run into trouble with the FDA banning imports from its Madhya-Pradesh-based facility after finding half a dozen violations, including data quality issues.
  • And more on the FDA - The Indian government has petitioned the FDA to allow Indian officials to be present during FDA inspections of domestic drug manufacturing units. This is in response to the increasing stringency of FDA inspections which apparently now take place without due notice to the facilities involved, as well as concerns about "cultural differences and body language" which may lead to miscommunications during the inspection process.