Medical device harms, hidden by regulator: policies akin to protection @USFDA


        

                   Modern medicine has been captivated by the  industry. In the name of people’s health, business and industry  receives a kind of  protection  by none other than regulator itself.  The report about USFDA,  hiding the adverse events or device failure and harm is just one example how  powerful  industry has become.  It is not always possible to identify  complications arising out of device failure and there can be possibility of  these  not  being reported. The numbers that are hidden may also represent a fraction of  actual number of harms related to device.  A sad truth of present era, where doctors are punished  and blamed for human errors or even  natural poor prognosis,  Medical industry remains not only  hidden behind the scenes, but  receives  policies akin to protection  by regulator.

USFDA ‘hid’ reports of medical device snags The US Food and Drug Administration (FDA), which claims to have stringent processes in place to ensure safety of medical devices, has been found to maintain a “hidden database” of reports of serious injuries and malfunction of devices. Since 2016, over a million incidents that were reported went to the hidden database rather than to the publicly available database of suspected device-associated deaths, serious injuries and malfunctions. This was revealed in an investigation carried out by Kaiser Health News, a US-based non-profit news service covering health news. The revelation has serious implications for India, which approves a lot of devices based on USFDA approval. KHN found that “about 100” devices including mechanical breathing machines and balloon pumps were granted “reporting exemptions” over the years. The investigation revealed that many doctors and engineers dedicated to improving device safety not only did not know the issues raised in these reports, they didn’t even know about the existence of the “hidden database” or the exemptions. While the agency hid such crucial information about device risks, lawsuits and FDA records show that patients have been injured, hundreds of times in some cases, noted KHN. According to KHN, FDA confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” an FDA spokesperson told KHN. The USFDA’s public database that tracks medical device failures, Manufacturer and User Facility Device Experience (MAUDE), receives thousands of medical device reports that are used to detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. These reports are submitted by mandatory reporters — manufacturers, importers and device user facilities — and by voluntary reporters — healthcare professionals, patients and consumers. MAUDE is used by doctors to identify problems or to check the safety record of a particular device. But they could reach the wrong conclusion as they would be unaware of and have no access to the reports on the “registry exempted” products, pointed out a former FDA official to KHN. For instance, KHN found that in 2016, while reports of only 84 stapler injuries or malfunctions were submitted to the public database, nearly 10,000 malfunction reports were included in the hidden database. Medtronic, which owns Covidien, considered to be the market leader in surgical staplers, had used reporting exemption. Surgical staplers are used to cut and seal tissues or vessels quickly, especially during minimally invasive surgeries and if the device fails the patient could bleed to death unless the doctors moved quickly to resuscitate the patient and seal the tissue/vessel. After the KHN report was published, the FDA has written to doctors expressing concern about the safety of surgical staples and staplers. The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions. The letter also acknowledged that the FDA was aware that “many more device malfunction reports during this time frame” were submitted as “summary reports”. The agency said it was analyzing the reports and that the results would be made public. According to the KHN report, the FDA has deemed manufacturers of over 5,600 types of devices including cardiac stents, leadless pacemakers and mechanical heart valves, eligible to file “voluntary malfunction summary reports”, one of the many exemption programmes. Ironically, in India, doctors and regulators have argued that FDA has the most stringent regulation for devices compared to regulators in Europe, Canada, Australia or Japan and have even sought to make it mandatory for devices to have USFDA approval to be eligible for government procurement tenders. This was especially evident during the efforts to cap the price of stents when top cardiologists argued for higher prices or even price cap exemption for USFDA-approved stents.

Black coat vs white coat. What if money part is taken out of medico legal cases?


What if  financial part  is taken out of medico-legal issues, like compensation and lawyers fee?  The cases will drop down drastically?  If money part is zero, only errors will be identified and punished. Few  will remain only for idea of revenge.  In an era where people cheat their brothers, sisters and spouses for money, it will be naïve to think that idea of money extracting from doctors does not exist.

Financial  zeroing  can be done  in larger public interest to  keep down the cost of medical expenses.  It is  because of career building of few professions, that medico-legal cases are being fueled. Medical errors and complications are integral part of the treatment . Even simplest of diseases carry some amount of risk.  These  will still remain, even if doctors are hanged to death. Natural complications, poor prognosis can be attributed to errors by clever lawyering and because of benefit derived by other professions.

     Many careers  are  shining in name of preventable deaths  and medical errors at the cost of medical profession.  The managers, right activists, media   and lawyers  have made their career and wealth out of it. Ask any doctor really, are these issues really preventable after a point.  The  line separating errors or natural complications is really blurred and arbitrary. People who work in life and death situation know it well that  even natural poor prognosis can be labelled and proved as error by retrospective analysis and wisdom of hindsight and more certainly with luxury of time at disposal for lawyers and courts.

     Lawyers  and courts  should also be given those fraction of moments to decide same as is available to doctors. Otherwise it becomes a unbalanced match specially when the amount of money which was paid to doctor to save a life was peanuts as compared to now being paid to punish him.

Doctor need to train themselves for “ Cool” communication with patients to save themselves.@ Supreme court on insensitive comments by Shimla Doc


Doctors are sitting ducks for revenge, which can be in many forms. It is necessary  not to make unnecessary comments during discussions with patients and relatives.  A sweet talk or even  stoic silence is still better than  making  irrelevant  and insensitive comments. Sometimes, in emergencies doctors are too busy, feeling harassed, and in heat of moment , they  utter some words. But later, no one will take into account the amount of distress in emergency situations.  Irrespective of the number of patients, try to refrain from uttering the words, which are non- professional.  But few words said  in disgust will be remembered by patient and interpreted by courts in  retrospective analysis can be held against the doctors..

Supreme court granted an additional Rs 10 lakh in compensation to a woman from hills in medical negligence case on finding about the insensitive  comment  made by doctor at hospital in Shimla

 Few points, which should be followed are as under to save themselves from future harassment. There can be many more.

  1. Do not have a word match with patient or attendants.
  2. If attendant are shouting or angry, restrain your mind and do not answer to give back in same words. Better to be silent.
  3. Try to avoid being in that situation, specially if you are being irritated and some thing goes out of your mouth.
  4. If the situation is arising because diagnosis is not clear or not able to treat, try to refer the patient, without  making  comments.
  5. Try to have cool and calm communication and make a record of it.
  6. Communication should be  regarding only professional matters. Rest all irrelevant communication to be avoided.
  7. Unreasonable and unrealistic demands are not uncommon . Just tell calmly about the same. Do not make angry or sarcastic comments.

But sometimes when  during ongoing  medico legal lawsuits, a feeling  of revenge prevails  or as guided by lawyers,  such uttered words may cause unnecessary problems.

  “Documenting  the communication”

  • examine, investigate, diagnosis , treat correctly and communicate
  • Make a note of plan of treatment and prognosis, and communicate to patient or attendants.
  • Sign yourself and ask the patient or nearest relative to sign.
  • It is not uncommon that relative will refuse to sign. In that case just write a note and mention that attendant refuses to sign.
  • It is also a common issue that after listening to everything, relative will say that he does not understand or will ask his uncle or aunt. These are difficult moments and commonly happen. Just make a note of everything. Besides it wastes crucial time.
  • Can use camera for communication in difficult cases.
  • Never rely on verbal communication. It has little value.  Commonly people refuse to admit verbal communication, and will say that they were not told anything.

As time for everything is limited in life, be it treatment, communication, consent or documentation. . “Talk less and write more”. You will be judged by documents after many years.

Doctors need to train themselves to restrain and avoid irrelevant comments, to save themselves.

Illegal Organ (Kidney)transplant trade : Defined as crime, but saves life


A paradox, where a defined crime saves a life and following law and regulation correctly will result in end of life. If some one is asked to choose between a certain death or follow regulations, the choice will be very predictable. A patient , who has an irreversible organ failure, will try to defy death at all cost. People who can afford, can not see their children or loved ones to die, just for the sake of following law and regulations. Genuine concern here will be that If a patient can be cured of disease, why he should be left to die for just regulations. The wish to live is the basic reason, why the procedures, which are termed illegal, will flourish. They will thrive underground or in countries, where laws are lax. Touts, agents and liaison managers are people, who will be beneficiary and mint money by organization of the procedure. The people who can afford, get gift of life, in the bargain.

Organ transplant may be termed illegal, in certain circumstances as defined by Law. But legal or illegal, it gives life . It gives another chance to people to live or have their kith and kin, children , spouses and parent to live another life. Because of gap in demand and supply, when legal means do not help, adoption of illegal means becomes a compulsion. If following law and rules means death, they are unlikely to be complied with.

The gap in demand and supply of organs is the reason behind these activities. Nearly four lakh people suffering from end stage kidney failure need transplant and only 8000 get it. (Times of India). The recipient has two choices for Kidneys. It can be living donor and deceased donor or cadaveric in cases of brain death. 90% come from relatives, rest are cadaveric. The rest has to undergo repeated dialysis to survive.

After the enactment of The Human Organ Transplantation Act of 1994, transplants became less in India. But it was followed by booming market of donors In other countries like Pakistan, Philippines .

But given the circumstances of life and death, the underground market may still be existent.

The ACT also allows unrelated donors to give one of the kidneys if there is sufficient evidence to show that they know the recipient for a long time and are donating organs out of affection. The loophole has potential to be exploited. The affection or the papers for affection can be easily generated in today’s era in lieu of money or other favors in case of high profile cases. Therefore, the mediator’s work becomes easier to generate the papers projecting affection and tutoring and training of donors and recipient.

Alternatively, the procedure can be done in nearby countries. Therefore the role of doctor or surgeon doing a transplant (although the key point) is much smaller than the agent organizing the whole process. Thereby the agents , who can manage and organize the show, are thriving. The wish to defy a certain death is stronger than following the regulation. That will remain so till demand supply gap reduced , better awareness for brain death, medical infrastructure, organ retrieval and transport and supporting facilities are uplifted. Till it happens, even if it is defined as crime, the fruits will outweigh the risks, because of shear margin of money temptations and wish to live.

Administrative and infrastructure deficiencies in health care: fail and blame for doctors


Adverse outcome in patients  can be  because of  many factors. Most of the time it is  serious illness, natural poor prognosis of disease, genuine complications or infections. Sometimes, It can be deficiency of equipment, malfunction, lack of infrastructure or facilities. There can be poor training or lack of  proper human resource and many others. There may be unintentional or human errors  by doctors or staff.  Root cause for most of the problems  can be traced to  administrative and system deficiencies rather than mistake of doctor. But since doctor is universal final link, when a patient dies, who  is visible on the bedside. So by application of an average wisdom, it is the doctor who will be held responsible for any problem or adverse outcome. Administration and people who are responsible for building infrastructure, procurement of  equipment and allocating finances or manpower  are not visible in forefront. It is very common for the doctors  to find themselves in a helpless situation, specially  in presence of  deluge of patients, difficult circumstances, scarce resources  and other  administrative issues.  In cases of adverse outcomes,  administration can   pretend to hide behind the common escape route by punishing doctors and hold them  guilty for the adverse events, as no other cause or person   is visible. By retrospective analysis  and  wisdom of hindsight along with luxury of time , it is a cake walk to give  verdict of one’s choice later, by fault finding analysis.

Non availability of ventilators or  malfunctioning  is not an issue, for which doctors are responsible. Procurement and allocation of funds is an  administrator’s domain.  But it is common that  doctors can be accused for not saving a life. They can be punished, dragged to court and even assaulted physically by crowds.  Dismal percentage of availability  of ventilators in Delhi Hospitals is a tip of the iceberg. This can be even  worse in other parts of the country. Ironically crowds visiting the hospitals only see and blame  the doctor, who is present on bedside and trying to save the patient. Patients hold them responsible for  malaise of the system  and fail to see the presence of  large  administration and industry,   that is behind  the scene. An unfortunate era,  when  the  doctors are blamed on  individual basis for system failure. In present circumstances, Lack of medical wisdom among masses is a cause of  huge discouragement for doctors.

With  High court being proactive in asking about the number of ventilators, the administration can not pretend to hide behind any more, but masses need to know the real truth.

Only 3.4% beds on Delhi Govt Hospitals have ventilator facility against the minimum requirement of 10% in every state run medical center. For  over 10,000 beds,  only 348 ventilators are there. That is an extremely low number.

52 of 400 ventilators in Delhi hospitals non-functional, state tells HC.

After 3-year-old Farhan died in the national Capital for an alleged want of proper ventilator care earlier this month, the state government of Delhi has told the High Court that a substantial number of ventilators in its government hospitals are not working. The state also told the HC on Tuesday that they were aiming to have a web portal up and running within two months, which would provide an online daily update on ventilator and bed availability across Delhi’s government hospitals.

After directions were issued by the HC, the state asked all its hospitals to provide a status update on ventilators and according to the information received from the government hospitals, up to 52 ventilators (13 per cent) of the total of 400 ventilator beds (including 300 ICU and 100 non-ICU) available in the hospitals are non-functional. “Fifty-two ventilators are non-functional and efforts are being made to get them repaired. The procurement of 18 ventilators is under process,” said the reply filed by the state government in the High Court on February 12.

The state government also stated in its reply that as far as maintaining real-time information on the availability of vacant beds in Delhi government hospitals goes, it may not be feasible to implement real-time availability information in the initial phase and the Delhi State Health Mission should be advised to start uploading information on bed availability in all the hospitals once a day in the morning.

The state government also said the State Programme Officer (MIS) of the Delhi State Health Mission has been requested, in

a letter dated January 31, to prepare a web portal for online bed/ ventilator availability and that such a Web portal should be made functional within two months.

The state government through an email sent on February 7 has also requested all the hospitals to complete repair, condemnation and procurement of ventilators at the earliest, according to Nutan Mundeja, Director General of Health Services.

After the matter of alleged unavailability of healthcare to Farhan came to light, the High Court moved a motion against the Union of India and sought a reply.

The number of ventilators as compared to bed strength in government hospitals is meager. “In private hospitals, there is one ventilator bed for every four normal beds. In government set-ups though, even as we have over 10,000 beds, we have only 348 ventilators. That is an extremely low number. Also, these ventilators may not be evenly distributed across the city,” pointed out  stated U Jhamb, Director, Professor and Head, Department of Paediatrics at the hospital.

 

Thousands Healthy deaths vs one hospital death. Perception of moral burden of negligence (# SUPREME COURT on pothole deaths)


There is a  infernal  difference in  the kind of  media  projection, burden of negligence and accountability of preventable multiple healthy deaths by civic negligence   as compared to one hospital death occurring due to severe  disease. In fact the burden of   negligence here in healthy deaths is massive and  these deaths are unpardonable. But reality is opposite.  Strangely  “alleged and perceived negligence” ( with no proof and no investigation )  in death of someone already having disease  and death in hospital  during treatment attracts more scrutiny and   stringent  punishment   as compared to a naked “negligence  in deaths of healthy people” in such cases  of civic negligence.  

Massive civic negligence  leading to  entirely preventable loss of lives. These incidents bring fore the misplaced priorities of media and society which too have  contributed to  some extent to these unabated ongoing preventable   deaths  of  thousands of  healthy people.

 

Deaths due to potholes ‘unacceptable’,  Supreme court

The bench,  said the number of deaths from 2013 to 2017 in accidents due to potholes indicated that the authorities concerned were not maintaining the roads. The Supreme Court Thursday expressed concern over 14,926 people being killed in road accidents due to potholes in last five years and termed it “unacceptable”. A bench said the large number of deaths caused due to potholes across the country was “probably more than those killed on border or by the terrorists”. Terming the situation as frightening, the top court had asked the Supreme Court Committee on Road Safety to look into the matter. The bench had also said that people who have lost their lives as a result of accidents due to potholes should be entitled to compensation. 

 

Multiple  Deaths  in healthy people by civic negligence :

Large numbers of death and morbidity happen amongst absolutely healthy population due to preventable causes like open manholes, drains, live electric wires, water contamination, dengue, malaria, recurring floods  etc. These deaths  of people are in thousands, and are almost entirely of healthy people, who otherwise were not at risk of death. In fact the burden of   negligence here is massive and  these deaths are unpardonable

 

       Single  Death in Hospital due to disease:

The media has always, instead, focused on the stray  and occasional incidents of perceived alleged negligence  in hospital deaths which could have occurred due to critical medical condition of patient. However an impression is created as if the doctors have killed a healthy person. It is assumed without any investigation that it was doctor’s fault.  Media has been responsible for creating a misunderstanding about the whole process of treatment and creating  something sensational out of nothing.

 

Point to ponder-Misplaced priorities:

Who is to be  blamed for  the deaths of healthy people which occur because of civic negligence? Here relatives may be helpless and  the vital questions  may go unanswered or taken as a routine.  There are no punching bags like doctor  for revenge. But on the contrary, any stray incident of death of an already ill patient is blown out of proportion by media forgetting the fact that thousands of patients are saved everyday by  doctors. But media instead chose to defame medical profession by igniting the emotions of people by sensationalizing death of diseased and ill,  who probably were already at risk of death and did not give due importance to highlighting prevention of healthy  and absolutely 100% preventable deaths.

Right issues raised at right time will save thousands of healthy preventable deaths. Multiple  healthy deaths should carry more burden of negligence than  one death due to disease.

      

Global corrupt medical (#implant) market & unholy nexus: tip of iceberg revealed


With aberrant  evolution of modern medicine and advancement  of  medical procedures, everything appears to be   controlled by medical industry. The  investors have gained  control of  the financial  game.  How large companies  create a web of  corrupt practices, and earn   huge profits, is a common prevalent sentiment.  Tip of the Iceberg has been revealed indicating inducements to  some doctors and dubious deals with hospitals. If these are the hallmarks of the big unregulated medical bazaar in India and some others, a rare case involving a global major has put a figure to it.

In a filing two months ago, the top financial regulator in the USA, the Securities and Exchange Commission (SEC), ordered the world’s leading manufacturer of orthopaedic implant devices, Stryker, to pay $7.8 million (over Rs 55 crore) in settlement for violating its corruption norms in India, China and Kuwait, documents accessed by The Indian Express reveal.

The settlement, recorded by the SEC on September 28, came after the Commission’s “accounting and audit enforcement” proceedings noted a number of “violations” by the company’s Indian subsidiary and its dealers. These “violations” include questionable payments to doctors for “consulting fees, travel, and other benefits” and “inflated invoices” issued to “mostly large, corporate hospitals”.

And that’s not all. In 2012, the anti-monopoly regulator, Competition Commission of India (CCI), fined an authorised distributor of Stryker India and two other firms Rs 3 crore for allegedly rigging bids, manipulating tenders and forming a cartel to sell equipment to the All India Institute of Medical Sciences (AIIMS) and Safdarjung Hospital, two of the largest government hospitals. In its scrutiny of Stryker’s India operations, including the findings of internal audits between 2010 and 2015, the US SEC concluded: “Payments intended to benefit HCPs (Health Care Providers) also lacked sufficient documentation, such as consulting fees paid to doctors without adequate explanation of the doctors’ consulting services or hours billed, and payments for HCP travel with documentation that appeared falsified…

“Additionally, the forensic review found missing or inaccurate documentation for numerous other transactions flagged as high-risk, including expenses related to consulting fees, travel, and other benefits to health-care professionals in India.”

The US regulator’s severe indictment of Stryker’s India operations is one of the most startling findings to emerge from the Implant Files investigation by The Indian Express and the International Consortium of Investigative Journalists (ICIJ) on the medical bazaar, where pharma majors hard sell their products without any regulation via a dubious nexus with hospitals and doctors.

Stryker India has four offices in the country — Delhi NCR, Mumbai, Chennai and Kolkata — and an annual turnover of Rs 300 crore in FY 2017-18, mainly from selling hip and knee implants, and medical devices for spine and neuro surgeries. The US-based parent company has a market cap of $58.87 billion with operations spread across 100 countries covering Asia, Europe, Africa and Latin America.

Dubious deals with hospitals:

Private hospitals that “requested inflated invoices from dealers  profited from their purchase of Stryker orthopaedic products by passing on the higher (invoiced) prices to their patients or their patients’ insurers, even as the hospitals paid the lower prices previously negotiated with Stryker India to Stryker India’s dealers”, the US SEC found.

In doing so, the SEC said, the dealers “allowed these private hospitals to gain a windfall from passing on the higher (invoiced) prices to their patients or their insurance companies”.

Linking Stryker to these deals, the regulator said: “Stryker India authorized these dealer transactions only after Stryker India’s management negotiated and approved the price that the hospitals would pay to the dealers. Thus, in determining the price charged to dealers, Stryker India’s management and the dealers specifically  negotiated the profit margin such dealers would stand to earn based on the difference between what hospitals paid the dealers and what the dealers paid Stryker India.”

SEC records do not identify the dealers involved. But documents maintained by CCI show that it had fined PES Installations, an authorised distributor, and two other firms, MDD Medical System and Medical Product Services (MPS), Rs 3 crore in April 2012 for a number of alleged irregularities in sale of equipment to AIIMS and Safdarjung Hospital, both in Delhi.

Responding to a questionnaire from The Indian Express on the SEC findings, Stryker said in a statement: “We are committed to working with our customers to make healthcare better while operating ethically and in compliance with all applicable laws and regulations.”

The US SEC, meanwhile, found a number of similar violations in Stryker’s operations in China and Kuwait, too. According to the SEC, it took into consideration “Stryker’s cooperation and remedial acts undertaken” while deciding to accept the company’s settlement offer to be paid “within 14 days”.

Unlike in India, the US has robust anti-corruption checks in place with the Foreign Corrupt Practices Act (FCPA), enacted in 1977, prohibiting the payment of bribes to foreign officials to assist in obtaining or retaining business, and mandating companies “to maintain accurate books and records”. In Stryker’s case, the SEC decided on a settlement after issuing a “cease-and-desist” offer to the company.

WHAT THE US REGULATOR FOUND

Inadequate oversight of dealers

* In 2012, in response to allegations of misconduct concerning Stryker India’s dealers, Stryker exercised its audit rights over three dealers in India. Those audits revealed insufficiencies in the financial record-keeping and internal accounting controls of all three dealers. Additionally, Stryker identified suspicious expenses by one dealer and instances of another dealer over-billing a hospital upon the hospital’s request. While Stryker took some corrective actions in response to these audits, including terminating one of the three dealers, the actions were limited to the three dealers audited.

* (The)deficiencies violated Stryker India’s agreements with its dealers. Specifically, the deficiencies in dealers’ financial record-keeping violated dealers’ obligation to “maintain complete and accurate records relating to [their] promotion, marketing, use and distribution of [Stryker] Products,” and the over-billing violated Stryker’s business conduct policy prohibiting participation in any improper payments. Despite the red flags raised during the 2012 audits, and numerous complaints reported to Stryker of dealer misconduct, Stryker did not act to determine the scope of dealer-inflated invoices until 2015.

* In 2015, Stryker performed audits of other dealers in India. The audits revealed that the practice of Stryker India’s dealers inflating invoices for the sale of Stryker orthopaedic products to certain private hospitals — an improper practice identified three years earlier in connection with the 2012 audits — had become more widespread.

Lack of accurate books, records

* From 2010 through 2015, Stryker India failed to make and keep complete and accurate books and records that reflected its transactions and disposition of assets. In particular, Stryker India recorded potentially problematic payments to its dealers and to HCPs, some of which lacked any supporting documentation reflecting a clear  business purpose.

* A forensic review of Stryker India’s general ledger for the period 2010 through 2015 found a complete lack of documentation for 144 out of 533 transactions selected as a sample of Stryker India’s highest-risk and most compliance-sensitive accounts.

* During the period of 2010 through 2015, Stryker was unable to provide any documentation for 27% of sampled high-risk transactions on Stryker India’s general ledger.

The SEC ordered Stryker to appoint an independent consultant, review and evaluate the company’s internal controls, record-keeping and anti-corruption policies, and procedures relating to use of dealers, agents, distributors, sub- distributors, and other such third parties that sell on behalf of the company. The SEC noted in its official filing: “Stryker fortified its existing compliance program, which is designed to prevent, detect, and remediate potential misconduct. This program develops, maintains, and implements corporate policies and standard operating procedures setting forth specific due diligence and documentation requirements for relationships with foreign officials, health care professionals, consultants, and distributors.”

The company has also retained an independent consultant to “formulate a work plan: that will be evaluated by the agency and Stryker to address the SEC’s findings”.

WHAT INDIA’S REGULATOR FOUND

Dealers rigging bids, forming cartel

* In April 2012, the CCI fined PES Installations, MDD Medical System and Medical Product Services for “bid-rigging and forming a cartel” in tenders for procurement of a Modular Operation Theatre (MOT) and other medical equipment at AIIMS and Safdarjung Hospital.

* The CCI also examined a contentious question: did the dealership agreement between Stryker India and PES violate sections of the Competition Commission Act? According to the official website of the Ministry of Corporate Affairs, the Act, enacted in 2002, aims “to

prevent practices having adverse effect on competition, to promote and sustain competition in markets, to protect the interests of consumers and to ensure freedom of trade carried on by other participants…”

* In its final order issued on April 16, 2014, based on the documents placed before it, CCI ruled that “according to the agreement struck with the dealer (PES Installations), Stryker could appoint any other firm as its dealer”. “However, according to the agreement, in this case PES Installations, the dealer could not sell products of any other company without the permission of Stryker,” the order said.

* The Director General appointed by CCI, under section 26 of the CCI Act, to conduct the investigation noted that the agreement that restricts PES to Stryker alone “impeded and restricts competition” and “constitutes violation of the law”.

* However, the CCI ruled in its final order that the agreement was “not violative of the law” on the grounds that “there are other competing products in the market” that are available to other “similarly placed” distributors.

The point to ponder here is that, with such unholy scenario and  milieu developing, where business deals and investors decide the treatment with  aberrant medical evolution taking place. Doctors involved with such big  companies will be promoted,  projected and survive. Will the honest doctors, who are not part of the game, be able to survive, sustain themselves or ultimately alienated  to  extinction?

source

 

Invisible medical harms of carpet-bomb treatments with FDC (fixed dose combination): @ Government prohibits 328 fixed dose combinations


Drug Technical Advisory Board said there is no therapeutic justification for the ingredients contained in the 328 fixed-dose combination or FDC drugs.

A fixed-dose combination or FDC drug contains two or more active ingredients in a fixed dosage ratio. It means it’s not the single drug but a combination of the two or more,  which may be   unnecessary for consumption.

  1. Antibiotic  resistance: Most harmful impact can be because of antibiotics in FDC.

– Logic is simple. If  some one  is  not able to recognize, whether it is a rat, cat, dog or tiger causing trouble, carpet bomb with combination of three or four   bombs.  Is it overuse of  weapons? Yes, it is. Similarly, abuse of multiple antibiotics has potential to cause massive antibiotic resistance, can have global harmful effect.

Quacks or by self medication,  antibiotics may be overused  and abused . Quacks  or alternative medicine doctors often prescribe FDCs as they are unable to pinpoint the exact cause of an illness and carpet-bomb patients with combination doses, in the hope that one of the drugs would work.

  1. Overuse of drugs: where one drug for example a paracetamol is required, patient will take three medicines.
  2. Increase in side effects: instead of one medication, patient will have side effects of all other medicines also.
  3. inadequate doses: If many drugs are combined in one, doses may be inadequate or less. So patient takes more drugs , but in adequate doses.
  4. Increase in cost: instead of one , the patient pays for three drugs, thereby increase in cost.

Government prohibits 328 fixed dose combinations 

     Painkiller Saridon and skin cream Panderm are among 328 fixed-dose combination or FDC drugs banned by the government to stop their “irrational use”. The health ministry says the ingredients in these medicines do not markedly add to the benefits that people can get from taking them. The order immediately bans the manufacture, marketing and sale of several common cough syrups, painkillers, and cold and flu drugs. The country’s drug advisory body, the Drug Technical Advisory Board or DTAB, has said there is no therapeutic justification for the ingredients in these drugs and they must be banned in public interest.

-The government has added restrictions to dosage and use of six more FDCs,  not among the 328 banned ones,  over their ingredients having no therapeutic value and posing a risk to consumers.

-The health ministry took the decision after the country’s top drug advisory body, the Drug Technical Advisory Board or DTAB, in a report said taking the 328 FDCs would be a health risk. India has some 2,000 FDCs as against a little over 500 in USA.

-It is a good move for public health. Individual drugs are approved by the centre, but some manufacturers make combinations of two drugs and get state licences.

-Mixing two drugs create a new medicine. For new medicine , pharma companies should approach the Drugs Controller General of India and apply for a fresh licence, conduct trials and  prove safety.

-In March 2010, the government restricted sales of 344 FDCs, a move that was challenged by pharma firms in court. The Supreme Court last December told the DTAB to ascertain whether FDCs should be banned from the market.

Every one is  calculative about  the loss of millions.  The invisible losses to human kind are still to be calculated.

 

Air pollution, Ultra fine dust causing millions premature deaths by heart attacks, strokes


Globally, 58% of outdoor air pollution-related premature deaths are due to heart disease and strokes, 18% due to chronic obstructive pulmonary disease, 18% from lung infections, and 6% because of lung cancer, said the World Health Organisation’s 2016 estimates.

Outdoor air pollution leads to 4.2 million premature deaths worldwide each year, with close to 60% of the deaths from heart attacks and strokes, according to the World Health Organisation. Finally, scientists appear to have figured out just how fine dust attacks the cardiovascular system.

An analysis of the effect of the different components of polluted air, including ozone, nitrogen dioxide, carbon monoxide and sulfur dioxide, showed that small particulate matter is the most damaging to the body’s vascular system, reported a team of researchers from Germany, England and the US.

Ultrafine dust (particulate matter 2.5 microns or less in diameter, or PM2.5) is the size of a virus and can penetrate the lung barrier to enter the blood system, leading to local inflammation in the blood vessels, the researchers found. This leads to atherosclerosis (plaque or fatty deposits in the side wall of the arteries), which stops blood flow to cause heart attacks, heart failure and irregular heartbeat (arrhythmias), they said.

It was PM2.5 and not nitrogen dioxide (NO2) — both of which are found in diesel exhaust emissions — which affected vascular function and posed a bigger risk to cardiovascular health, found the study published in the European Heart Journal on Thursday.

Heart disease is the leading cause of death in India, which has 14 of the world’s most polluted cities by small particulate matter concentration (see box). According to the Global Burden of Disease report, an estimated 1.1 million deaths in India were linked to PM2.5 air pollution in 2015.

PM2.5 inhalation causes hypertension, insulin resistance, and endothelial dysfunction with impaired vasodilation (stiffening of the arteries), inflammation and clot formation, which can trigger heart attack and stroke. “The fine dust particles are chemically formed mainly in the atmosphere from emissions from traffic, industry, and agriculture. In order to achieve low, harmless concentrations, emissions from all these sources need to be reduced,” said lead author Thomas Münzel, director of cardiology at the Medical Center of Johannes Gutenberg University Mainz, Germany.

Governments need to introduce strong regulatory policies to regulate emissions and invest in clean transport, green power generation and efficient waste management.

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