Editor in Chief Dr KK Aggarwal, Padma Shri Awardee


Dated: 19th June, 2019

Clinical Case

Does a very low coronary artery calcium CAC score signify very low risk?

A 46 year old female came with atypical chest pain with reported wall motions on echo and questionable CAD on CT angiography. She was put on treatment for the last six months and was now advised EECP and chelation therapy. The patient came for a third opinion.

A: On reviewing the CT report it was found she had a coronary calcium score of zero. She was put of lifestyle advise.

Discussion

American Heart Association: CAC score of zero (CAC=0; ie, no calcified plaque detected) indicate that

1.the presence of atherosclerotic plaque, including unstable or vulnerable plaque is highly unlikely

2.that the presence of significant luminal obstructive disease is highly unlikely (negative predictive value on the order of 95% to 99%)

3.that the risk of a cardiovascular event in the next 2 to 5 years is quite low (0.1 per 100 person-years).

4.CAC=0 is useful in the emergency room setting as a tool to rule out myocardial ischemia in symptomatic patients.

The presence of CAC is highly sensitive for the presence of =50 percent angiographic stenosis in moderately specific, especially in older patients.The absence of CAC, particularly in an asymptomatic patient, is highly predictive of the absence of significant coronary artery stenosis and implies a favorable prognosis.

CAC screening, especially for borderline and intermediate risk patients, can enhance the prediction of risk in asymptomatic individuals and increase the predictive value of the Framingham Risk Score.Among asymptomatic patients with a low Framingham risk score (<10 percent 10-year risk), only a small number (less than 15 percent) of those with CAC will have a cardiac event over the ensuing five years.

CAC screening is unlikely to benefit low- or high-risk (>20 percent 10-year risk) patients, and is not recommended.It has not been established that instituting or intensifying pharmacologic risk factor modification in asymptomatic patients with CAC improves outcomes.


Fecal Transplant Linked to Death, the FDA Warns

As per FDA two patients received donated stool that had not been screened for drug-resistant germs, leading it to halt clinical trials until researchers prove proper testing procedures are in place.

Fecal transplants have come into increasing use to treat severe intestinal disorders, particularly an infection caused by a bacterium called Clostridium difficile, which can be deadly and tends to occur in hospitalized patients who have been heavily treated with antibiotics. The idea behind the transplants is to use stool from a healthy donor to restore the normal balance of bacteria and other organisms in the intestine, the microbiome.

Both transplants came from the same donor’s fecal matter. The report does not state whether the fecal material was given in liquid form as an infusion into the digestive tract or swallowed as pills.

Other samples from the same donor were tested after the patients got sick. The samples were found to harbor the same dangerous germs found in the patients, known as multi-drug-resistant organisms. They were E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, which makes them resistant to multiple antibiotics. The stool had not been tested for the germs before being given to the patients.

The F.D.A. on Thursday issued a warning to researchers that stool from donors in studies of fecal transplantation should be screened for drug-resistant microbes, and not used if those were present. It is also warning patients that the procedure can be risky, is not approved by the agency and should be used only as a last resort when C. difficile does not respond to standard treatments.


Supreme Court defers hearing of petition seeking protection for Doctors

The Supreme Court has deferred the hearing in the petition seeking protection for Doctors in the government hospitals.

The Court was of the view that while the larger question of protection for Doctors needs consideration, the matter is not urgent anymore given the fact that the strike by the Doctors in West Bengal, as well as other States, has now been called off.
The Vacation Bench of Justices Deepak Gupta and Surya Kant thus directed that the petition be listed before an appropriate Bench after vacation.
The questions relating to the kind of protection and who shall be responsible for providing the same will be considered by the Court......read more


HR/June 19/4: E-cigarettes for smoking cessation in adults

(Excerpts from February 2019 Uptodate): There is a growing appreciation that use of e-cigarettes poses fewer risks compared to smoking traditional cigarettes in adults.

A randomized trial published in the New England Journal of Medicine investigating interventions for cessation from combustible tobacco smoking compared three months of e-cigarettes with nicotine replacement therapy (NRT, approved by the US Food and Drug Administration for smoking cessation); both groups received at least four behavioral support sessions (N Engl J Med. 2019;380(7):629)......read more


The Key To Health

To stay healthy, one needs to eat right, get plenty of exercise and rest, and avoid bad habits such as smoking. But, now it is said that "what you believe in" can have a big impact on health and longevity. There have been a lot of studies that show how patients with strong spirituality can improve their health from a variety of chronic conditions, like hypertension, heart disease, recover from surgery,.....read more


Healthcare News Monitor

Encephalitis toll hits 103, govt announces more ICUs for Bihar

Live Mint- Neetu Chandra Sharma

Five virological laboratories are to be set up across districts in Bihar, health minister Harsh Vardhan said on Monday after more than 103 children died of encephalitis in Muzaffarpur district. The districts will be decided in consultation with the state government and can be funded through the National Health Mission (NHM), he said. Harsh Vardhan visited Bihar on Sunday, where he met the families of the children suffering from encephalitis and have been admitted in hospitals. An official release issued by the district administration on Monday said 103 children have died so far at Sri Krishna Medical College and Hospital (SKMCH) and Kejriwal Hospital in Muzaffarpur.

Pfizer to buy cancer drug developer Array for $10.64 billion

ET Healthworld- Reuters

Pfizer Inc said on Monday it would acquire Array Biopharma Inc for $10.64 billion in cash, giving it access to the target's approved drugs for skin cancer and the targeted cancer medicines in its pipeline. The offer of $48 per Array share represents a premium of about 62% to the stock's close on Friday. Array's shares. Pfizer has been investing in cancer drugs and gene therapies in the face of competition for its blockbuster pain drug Lyrica. The U.S. Food and Drug Administration last year approved Array's oral combination treatment for use in patients with the deadliest form of skin cancer.

Maharashtra sets up 315 drug retail stores under PMBJP scheme

Pharmabiz- Shardul Nautiyal

Fulfilling the government's mandate towards making medicines affordable for the common man, Maharashtra has set up around 315 drug retail stores under the Prime Minister's flagship programme -‘Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana’ (PMBJP). As of today, 5,303 PMBJP centres are functional in 29 states and 6 Union Territories across the country and generic medicines worth Rs.417 crore have already been sold through PMBJP Kendras since its inception in 2008. PMBJP was launched by the Union ministry of chemicals and fertilizers with an objective of making available quality generic medicines at affordable prices to all. Under this scheme, unbranded generic medicines of good quality are made available through outlets called PMBJP Kendras. In order to ensure quality of medicines sold through PMBJP Kendras, the medicines are procured only from WHO-GMP certified manufacturers.

Advanced burner technology improves efficiency & safety in pharma industry operations: Dhruv Goyal

Pharmabiz- Nandita Vijay

The pharmaceutical manufacturing requires specialist heat transfer fluids for precise temperature control across the cooling and heating phases. This is where adoption of advanced industrial burners needed to improve the efficiency and safety in pharma operations, said Dhruv Goyal, MD, De Novo. A burner mixes fuel and air using a flaming device which provides a platform for combustion. Over the recent years, huge strides have been made in the area of burner technology and its associated controls. These developments have resulted in engineering burners that offer the foremost correct management of the fuel or air magnitude throughout the burner target range and extended flip down magnitude relation with low levels of excess air and the highest practicable operating efficiency, he added. Now, older process heating systems can often be given a new lease of life by replacing the burner with one of the latest models, not only extending the life of the system but also improving capability and protection, he noted.

KC& DA urges Karnataka state DC not to approve e-pharmacy at the cost of patients

Pharmabiz- Nandita Vijay

Even as the Union health ministry is examining the issues related to e-pharmacy to provide operational direction for online sale of drugs in the country, the Karnataka Chemists & Druggists Association (KC&DA) has urged the state drugs controller not to approve the business model of e-pharmacy at the cost of the patients. In a communiqué to the Karnataka state drugs controller, the Association has apprised the regulator about the concerns of the pharmacy trade on the e-pharmacy. The association wanted the state drug regulator to take up the issue with the CDSCO officials at the meeting called by the Drugs Control General of India where the state drug controller is a member invitee.

Pfizer to buy cancer drug developer Array for $10.64 billion

ET Healthworld- Reuters

Pfizer Inc said on Monday it would acquire Array Biopharma Inc for $10.64 billion in cash, giving it access to the target's approved drugs for skin cancer and the targeted cancer medicines in its pipeline. The offer of $48 per Array share represents a premium of about 62% to the stock's close on Friday. Array's shares. Pfizer has been investing in cancer drugs and gene therapies in the face of competition for its blockbuster pain drug Lyrica. The U.S. Food and Drug Administration last year approved Array's oral combination treatment for use in patients with the deadliest form of skin cancer.