Weight Gain Doesn’t Diminish Benefits of Giving Up Smoking

The weight gain that often accompanies smoking cessation temporarily raises the risk for developing type 2 diabetes, but it doesn’t diminish the overall benefits in reducing cardiovascular and all-cause mortality, new research shows.

The findings, from three large US cohort studies of healthcare professionals, were published online August 15 in the New England Journal of Medicine by doctoral student Yang Hu, SM, from the departments of nutrition and epidemiology at Harvard T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues.

Among more than 150,000 total participants from the longitudinal Nurses’ Health Study, the Nurses’ Health Study II, and the Health Professionals Follow-up Study, those who stopped smoking and then gained weight had an increased risk for developing type 2 diabetes for about 5 to 7 years compared with those who continued smoking, but the risk dropped after that.

In contrast, significant reductions in both cardiovascular and all-cause mortality compared with current smokers occurred throughout the same time period, even among those who gained weight.

Weight change within 6 years after quitting smoking explained 68.4% of the increased risk for type 2 diabetes, the authors estimate.

“It’s been known that quitters may have an elevated risk of developing diabetes or worsening glucose tolerance in the first few years after quitting, and this may discourage smokers from quitting, but our study shows that it is the weight change after quitting that determines diabetes risk — so as long as quitters minimize their weight gain, their diabetes risk will not increase and, over the long run, is reduced,” said senior author Qi Sun, associate professor in the Department of Nutrition at Chan, in a statement from Harvard.

Benefits of Quitting Far Outweigh Risks: Action Still Needed on Smoking

In an accompanying editorial, Steven A. Schroeder, MD, from the Department of Medicine, University of California, San Francisco, writes: “For clinicians, the main message from the article by Hu et al. is that the cardiovascular and overall mortality benefits of stopping smoking far outweigh the risks of acquiring type 2 diabetes.”

However, Schroeder cautions, “the participants in the three cohorts, all health professionals, had health risks and behaviors that did not mirror those of smokers in 2018, who tend to be concentrated among vulnerable populations.”

And he points out that although the current US smoking prevalence is at a provisional low of 13.9%, that still leaves 37 million current smokers.

“Much greater reduction in smoking prevalence is possible. That laudable goal deserves aggressive action.”

Diabetes Risk After Smoking Cessation in Those Who Gain Weight

From the three large databases, 162,807 participants without diabetes, cardiovascular disease, or cancer at baseline were analyzed. During a mean of 19.6 years of follow-up, 12,384 were diagnosed with type 2 diabetes.

Overall, recent quitters — those with 2 to 6 consecutive years since smoking cessation — had a higher risk for developing type 2 diabetes than did current smokers.

When analyzed by degree of weight gain, those who didn’t gain any weight after quitting did not have a greater diabetes risk than did current smokers (hazard ratio [HR], 1.08; not significant). The increased risk was also nonsignificant (HR, 1.15) for those who gained just 0.1 to 5.0 kg (0.2 to 11 lbs).

In contrast, those who gained more than 5.0 kg had significantly increased risks for developing diabetes, with HRs of 1.36 among those gaining 5.1 to 10.0 kg and 1.59 among those gaining more than 10.0 kg.

However, the risk peaked at 5 to 7 years after quitting and then gradually decreased.

Mortality Benefits of Smoking Cessation Maintained

The mortality analysis involved 170,723 study participants without cardiovascular disease or cancer at baseline. During follow-up, there were a total of 23,867 deaths, of which 5492 were due to cardiovascular disease.

Compared with current smokers, deaths due to cardiovascular disease were reduced among those who had stopped smoking regardless of weight change status.

HRs — all significant — were 0.69, 0.47, 0.25, and 0.33 for recent quitters with weight gains of 0, 0.1 to 5.0 kg, 5.1 to 10.0 kg, and more than 10.0 kg.

Among those who had quit smoking more than 6 years previously, the HR for cardiovascular death was 0.50.

For deaths due to any cause, the corresponding HRs for the different categories of weight gain were 0.81, 0.52, 0.46, 0.50, and 0.57, also all statistically significant.

While the cardiovascular mortality advantage tended to wane 10 to 15 years after stopping smoking, the risk for cardiovascular death never reached the level in current smokers, Yu and colleagues report.

Quitters: Don’t Be Deterred by Potential Weight Gain

In the statement, Yu noted, “Smokers shouldn’t be deterred by potential weight gain after quitting because the short-term and long-term reduction of cardiovascular disease risk is clear.”

“However, quitters may want to consider eating a healthful diet and engaging in physical activities to minimize weight gain to keep their diabetes risk at bay and to maximize the health benefits of quitting.”

Supported by research grants from the National Institutes of Health. Hu and Schroeder have disclosed no relevant financial relationships.

N Engl J Med. Published online August 15, 2018. Abstract, Editorial

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Wellcome Cancer Research Funding Lost Over Bullying Allegation

Nazneen Rahman, a cancer researcher who has said she would step down from her post at Institute of Cancer Research following bullying allegations, has also lost millions in grant money, the Guardian reports.

Forty-five individuals, both current and former colleagues, accused Rahman of bullying, it adds, saying that she announced she would resign from her post as head of genetics and epidemiology. That announcement, the Guardian notes, comes after an independent investigation into the allegations, but before any disciplinary action.

The Wellcome Trust enacted anti-bullying and harassment policies earlier this year. At the time it said it might sanction researchers who have been found to have bullied or harassed others separately from what the individual’s institution does.

According to the Guardian, it’s under those that Rahman has lost her funding. The Wellcome Trust tells the Guardian that the summary of the investigation that it saw gave “considerable cause for concern” and that it would be terminating or transferring whatever remains of the £7.5 million ($9.5 million) in funding it awarded Rahman. It also barred her from seeking additional funding for two years.

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Tecan accelerates genomics strategy with acquisition of US’ NuGEN Technologies

• Acquisition of US-based NuGEN expands Tecan’s dedicated solutions offering into new market segment of next-generation sequencing (NGS) reagents and increases overall recurring revenues
• NuGEN provides innovative NGS kits and genomic sample prep reagents for the fastest growing field within the genomics area
• NuGEN to become part of Tecan’s Life Sciences Business, leveraging Tecan’s global presence and strong position in NGS sample preparation automation platforms
• Consideration of USD 54.5 million (CHF 54.1 million) representing less than four times expected fiscal year 2018 sales of NuGEN
• Tecan anticipates to triple NuGEN’s sales by 2023
• Total sales of more than CHF 75 million from execution of broad genomics strategy expected by 2023, including NuGEN and new workstations
• Closing of the transaction expected within the coming weeks

The Tecan Group (SIX Swiss Exchange: TECN) announced today the acquisition of US-based NuGEN Technologies, Inc. to further expand Tecan’s dedicated solutions offering into the new market segment of next-generation sequencing (NGS) reagents and thus further increasing Tecan’s overall recurring revenues. NuGEN is a leading provider for innovative NGS kits and genomic sample preparation solutions for the fastest growing field within the genomics area, serving customers in life science research and applied markets. As part of Tecan’s Life Sciences Business, NuGEN will benefit from Tecan’s global presence, customer base and strong position serving the market with automation platforms optimized for NGS sample preparation.

The purchase consideration of USD 54.5 million (CHF 54.1 million) will be fully paid in cash and represents a valuation of less than four times expected fiscal year 2018 sales of NuGEN. Tecan anticipates to triple NuGEN’s sales in the next five years by leveraging its global presence and by expanding sales capabilities in key regions. Together with an accelerated execution of its broad genomics strategy enabled by this transaction, including NuGEN and new dedicated workstations which are already under development, Tecan expects to generate total annual sales of more than CHF 75 million through this initiative by 2023. While currently modestly loss making, Tecan expects the transaction to become accretive to earnings per share (EPS) before transaction-related amortization for 2022. The closing of the transaction is anticipated within the coming weeks. 
An expected impact of the acquisition on Tecan’s 2018 financial results was published today in a separate press release announcing financial results for the first half of 2018.

Tecan CEO Dr. David Martyr commented: “NuGEN’s innovative NGS kits and genomic sample preparation solutions are an excellent complement to our industry-leading automated workstations for genomic applications. Through this acquisition, we are accelerating our broad genomics strategy and further increase our recurring revenues. With further dedicated solution offerings in one of the fastest growing market segments in life sciences, we will be able to enhance the above market average growth of Tecan in years to come. NuGEN will become our center of excellence for NGS reagents and we are delighted to welcome the new colleagues into Tecan.”

Nitin Sood, CEO of NuGEN and designated Vice President and General Manager of Tecan’s NGS reagents business, said: “We are very excited to join forces with Tecan to combine our market leading Next Generation Sequencing library preparation technologies with Tecan’s core competencies in automation and detection to deliver complete solutions to our customers. Tecan’s global footprint and depth of capabilities will accelerate our innovation pipeline, bringing benefits to our customers and employees.”

NuGEN provides innovative genomic sample preparation for next-generation sequencing (NGS) and microarrays for a broad range of sample types including RNA and DNA from whole tissues, preserved and prepared tissue samples (FFPE, Formalin-Fixed Paraffin-Embedded), single cells and liquid biopsies such as from blood samples. An example of NuGEN’s innovation capabilities is the newly launched Celero(TM) DNA-Seq with NuQuant library system which provides researchers with a simplified library preparation workflow with integrated quantification for DNA sequencing. Next-generation sequencing technologies are currently transforming the life sciences, e.g. the field of cancer research, due to the wealth of genetic information obtained.

https://bit.ly/2nS27YV

UK in talks with Biogen after rejecting spinal muscular atrophy med on price

Cost-effectiveness body NICE has rejected Biogen’s Spinraza (nusinersen) therapy for the rare genetic muscle wasting disease spinal muscular atrophy (SMA) because of its high cost – but is in further discussions with the manufacturer to strike a special deal to make the therapy available on the NHS.

NICE is now in talks with Biogen over a “managed access” scheme to limit the financial risks to the NHS.

For example the first agreement of this type allowed patients access to BioMarin’s Vimizim (elosulfase alfa), where patients remain on the drug as long as it continues to work.

These schemes are rare outside of the Cancer Drug Fund, which provides interim access to oncology medicines where evidence is uncertain.

Managed access schemes are also used in NICE’s Highly Specialised Technologies assessments for very rare drugs – but the SMA patient population is too large for Spinraza to be considered with this scheme.

People with the most severe forms of SMA usually die before the age of 2. There are currently no active treatments targeting the underlying cause of SMA so the condition is managed through supportive care which aims to minimise the impact of disability, address complications and improve quality of life.

Spinraza is the first treatment to address the cause of motor neurone degeneration in SMA; it is injected directly into the spine and is a lifelong treatment.

But NICE’s independent advisory committee raised concerns that Spinraza’s long-term survival benefit is based on “optimistic assumptions” and is “highly uncertain”.

The cost-effectiveness body also said it had difficulty assessing the utility value of Spinraza – the wider value of the drug to society.

Including an assessment of the impact of the disease on carers added to the uncertainties, said NICE’s assessors.

But NICE’s main problem with Spinraza is its enormous cost – £450,000 per patient for the first year and £225,000 for subsequent years.

Based on the drug’s list price, the committee found that the NHS would have to pay £400,000 – £600,000 per quality adjusted life year (QALY) gained.

This is well above NICE’s usual upper cost-effectiveness threshold of £30,000 per QALY gained in its usual single technology appraisal.

Had NICE used the highly specialised technology programme to assess Spinraza, it would still have been too expensive – the upper limit for medicines that extend patients’ lives by 30 years or more is £300,000 per QALY.

A proposed confidential discount means the costs are too high for the NHS, according to NICE.

NICE’s Meindert Boysen said: “The committee was willing to be flexible because of the nature of the condition and the paucity of the evidence, but the very high cost of nusinersen meant it could not recommend the drug as a cost effective use of NHS resources.

“Nusinersen is a promising treatment that has been shown to improve a range of outcomes important to patients. We are actively engaging with Biogen to discuss how they might address the uncertainties identified by the committee, while demonstrating the potential for nusinersen to be considered cost effective and managing the risk to the NHS of allowing access to this treatment.”

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Ohio cracks down on PBMs as audit shows egregious Medicaid spread pricing

Ohio is bearing down on pharmacy benefit managers (PBMs) for wasting taxpayer dollars through “spread” pricing.

Spread pricing models allow PBMs to generate revenue for themselves by charging Medicaid (and thus, taxpayers) more than the amount they reimburse pharmacies.

On Thursday, Auditor of State Dave Yost released findings that PBMs charged Medicaid not only a nearly 9% spread across all drugs but also a 31% spread among generic drug prescriptions filled between April 1, 2017 and March 31, 2018.

PBMs collected more than $2.5 billion from plans during that period, including $662.7 million from generic drugs and almost $1.25 billion from brand-name drugs. Of the $2.5 billion, nearly $225 million was generated through spread pricing, including $208 million from prescriptions for generics.

In a lengthy rebuttal, CVS Health, which serves as one of the state’s PBMs, said it has saved Ohio taxpayers $145 million annually by negotiating drug prices for Medicaid managed care plans. The company also said CVS Caremark passes 100% of government-mandated rebates to Medicaid managed care clients.

“In other words, we do not keep any amount of a drug manufacturer’s rebate for Medicaid prescriptions in Ohio,” the company wrote.

CVS added that the spread pricing was chosen by managed care insurers instead of paying an administrative fee. The company said the money “funds vitally important benefit management services we provide to clients, such as clinical and customer support, programs to improve medication adherence, management of the drug formulary, and other services.”

Last week, CVS disclosed that it keeps just 2% of rebates from commercial clients and expects to make approximately $300 million on rebates in 2018. The audit came on the heels of Ohio Medicaid Director Barbara Sears’ letter informing the state’s five managed care plans that they may no longer contract with PBMs that engage in spread pricing. The state will require PBMs in its Medicaid program to move to a “pass-through” pricing model instead, in which PBMs receive a flat administrative fee and may only bill the state for what they pay pharmacies. In contrast to spread pricing, pass-through pricing will be cost-neutral for the state and improve transparency for taxpayers, Sears explained.

The plans must terminate contracts with PBMs that use a spread pricing model by January 1, 2019. CVS said it is “actively working” with the state to restructure its contract to implement pass-through pricing.

Until then, the state will design the pass-through pricing program, conduct actuarial analyses to ensure budget neutrality, conduct its annual survey of pharmacy dispensing costs, and update and negotiate PBM contracts as needed.

“The more we learn, the more troubling this becomes,” Yost said in his announcement. “We cannot be content to accept a ‘black box’ in the delivery of public services.”

https://bit.ly/2wc6rWQ

‘Medicare for all’ tricky issue for Dems

“Medicare for all,” the concept of expanding Medicare into a single payer for seniors and non-seniors alike, has divided the House Democratic caucus ahead of November’s midterm elections.

Single-payer advocates continue to push the idea, but Democratic strategists hope the issue remains fringe at best, making it fodder for debate in the primaries but unlikely to define Congress’ healthcare platform for 2020.

An April poll on the subject found a slim majority—51% of the public—favors a single-payer system, according to the Washington Post and Kaiser Family Foundation, which conducted the survey.

As far as the actual vote goes, looking district by district, the lead goes away, operatives say. Most Americans get coverage through their employers, and those people are mostly satisfied with the way things are.

The baby boom generation also is opting for Medicare Advantage coverage, making it difficult for members of both political parties to believe a large-scale amorphous shift to an expanded version of Medicare can ever be a political winner. Both Republicans and mainstream Democrats are messaging accordingly.

“The American people don’t have an appetite for scrapping everything and starting over,” said Brad Woodhouse, who as campaign director of the liberal advocacy group Protect Our Care is overseeing a massive campaign effort across 14 mostly swing states. “That applies to scrapping the Affordable Care Act for single-payer and scrapping the Affordable Care Act for repeal.”

One insurance industry lobbyist said he believes the “Medicare for all” message will continue to gain momentum because its simplicity appeals to people after the last few years of turmoil over the individual market. Democrats may be pushed to the left before voters understand the complexity of a single-payer plan, he added, and Republicans who don’t want to touch repeal-and-replace again may find themselves on the defensive pushing back against “Medicare for all.”

Adding fuel to the debate, an economist from the libertarian Mercatus Center of George Mason University predicted massive reductions for providers as the sole restraint to the healthcare costs spurred by the “Medicare for All” plan put forward by Sen. Bernie Sanders (I-Vt.). The white paper calculated the plan would cut provider payments by more than $380 billion in the first year and nearly $660 billion in 2030.

Ceci Connolly, president of the Alliance of Community Health Plans, compared today’s inter-party debate to the massive public backlash against the continuous double-digit premium increases of the late 1990s. But Connolly says the tone of the discussion has changed. “That era was very different than where we are today, when we have small but vocal groups with a very sharp opinion of what they want from the healthcare system,” she said. “I don’t see that opinion broadly across the electorate—probably just within the base of the two political parties.

Primary challenges

Democratic strategists had hoped to avoid much discussion of creating a single-payer system, fearing it would hurt the party as it angles for a majority in at least one branch of Congress. In the wake of the GOP’s failed measure to repeal Obamacare, Democratic operatives saw an opportunity and urged incumbents and challengers to attack Republicans and the Trump administration for its acts of ACA sabotage.

Woodhouse cited the Trump administration’s recent refusal to defend the ACA in a Texas federal court, along with the nomination of Brett Kavanaugh to the U.S. Supreme Court, as gifts the Democrats needed to galvanize voters around healthcare. Early primary elections favored Democrats who ran on shoring up the ACA and promoting the so-called public option.

But then progressive Democratic candidate Alexandria Ocasio-Cortez defeated longtime Rep. Joe Crowley (D-N.Y.), a rising star in the party who was considered a shoo-in as next Democratic speaker. A former campaigner for the presidential bid of Sanders—the “Medicare for all” torchbearer—Ocasio-Cortez is now criss-crossing the country to campaign for fellow progressives.

Often joined by Sanders, Ocasio-Cortez is calling for the creation of a single-payer system, with mixed success. She pushed hard for progressives running on “Medicare for all,” but Brent Welder, running for GOP Rep. Kevin Yoder’s Kansas seat, and Abdul El-Sayed, running for Michigan governor, both lost. Welder lost by about 2,000 votes and El-Sayed by a margin of 21 percentage points. Those losses, however were followed by wins by two single-payer supporters, Rashida Tlaib of Michigan and Ilhan Omar of Minnesota.

They’ve got the fever

But “Medicare for all” fever had already hit the House. Shortly before lawmakers left Washington for August recess, Rep. Pramila Jayapal, a Democratic freshman from Washington state, launched the 60-plus member Medicare for All Caucus. Her explicit goal is to write substantive single-payer policy over the next two years in time for the 2020 election. Significantly, several in the crowd of potential contenders in the 2020 primary signed onto Sanders’ “Medicare for all” legislation: including Democratic Sens. Kamala Harris of California, Cory Booker of New Jersey, Elizabeth Warren of Massachusetts and Kirsten Gillibrand of New York.

In a burst of drama, Rep. Keith Ellison (D-Minn.), the lead sponsor on the House single-payer bill, suggested progressive groups should call out Democratic lawmakers who don’t back “Medicare for all.” “We need to run ads pointing out to constituents people who are not on the bill,” Ellison said at a single-payer conference last month, according to the Star Tribune in Minneapolis.

This rankled Rep. Betty McCollum, a fellow Democrat from Minnesota. McCollum’s office did not respond to a request for comment for this story, but in a statement to the Star Tribune the lawmaker criticized Ellison’s comments. “Mr. Ellison’s rhetorical attack on Democrats fighting to gain control of the U.S. House is extremely disappointing, especially since he’s quitting Congress and abandoning his own legislative effort,” McCollum told the newspaper.

Other House Democrats want to slow down the messaging war. “For each member, they really have to think about it on a district basis,” said Democratic Rep. Marc Veasey who represents a district in Dallas-Fort Worth that has one of the lowest insured rates in the country. “Everybody wants to nationalize everything, but the fact of the matter is that everyone needs to figure out how to address this. I think everybody’s concerned about healthcare.”

Rep. Raul Ruiz (D-Calif.), a physician who sits on the House Energy & Commerce Committee, offered a similar sentiment when asked whether the “Medicare for all” message could be detrimental for Democrats. “I think we have to be very cautious on how we achieve universal care because if we don’t get it right, it’s not going to come up again for another century,” Ruiz said.

On the state level, legislatures and governors are wading into the minefield of industry opposition with a span of measures, including single-payer proposals. This could offer a glimpse of what the fight to come would look like should a “Medicare for all” coalition rally around a detailed plan.

One major point of contention centered on a California proposal that moved in the universal payment direction through an all-payer model. The bill by state Democratic Rep. Ash Kalra would have moved California’s providers to an all-payer rate to be set as a percentage of Medicare by a special commission. Backed by patient advocates and labor unions who decry how healthcare costs are cutting into wage growth, the measure drew tremendous opposition from industry groups, especially hospitals that alleged the bill would cut provider pay by $18 billion in the first year alone.

The legislation never got passed by a committee, but a spokesperson for Kalra said he would likely introduce it again next year.

Legislators in New York and California both introduced single-payer bills, and Democratic gubernatorial candidates from California to Michigan to Massachusetts are also calling for single-payer, absent much detail.

It isn’t clear how far states can go under the Trump administration. CMS Administrator Seema Verma took aim at “Medicare for all” in a speech at the Commonwealth Club in California, saying the agency would likely deny single-payer waivers. “It doesn’t make sense to waste time on something that’s not going to work,” she said, citing the cost of the program and Medicare’s pending insolvency.

What’s the new status quo?

If Democrats take control of the House, or even both chambers of Congress, they could serve mainly to block Trump’s moves. While mainstream Democrats say they want to stabilize the ACA, Trump has in the first half of his term worked to reduce the law’s role, promoting the use of short-term plans and association health plans. The GOP-majority Congress has delayed and repealed Obamacare taxes including the individual mandate.

“Medicare for all” proponents want to fine-tune their message for 2020, Connolly said, but she’d prefer Congress to focus on correcting the existing system.

Similarly, liberal policy advocate Woodhouse said it would be more effective to support correcting the ACA’s flaws. “If the point is to maintain what people have and strengthen it, and if that’s where the American people seem to be, the most effective political argument for Democrats is to expose Republicans for wanting to rip away healthcare for millions of people,” he said.

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U.S. tech giants plan to fight India’s data localisation plans

U.S. technology giants plan to intensify lobbying efforts against stringent Indian data localisation requirements, which they say will undermine their growth ambitions in India, sources told Reuters.

U.S trade groups, representing companies such as Amazon, American Express and Microsoft, have opposed India’s push to store data locally. That push comes amid rising global efforts to protect user data but is one that could hit planned investments by the firms in the Indian market, where the companies currently have limited data storage.

The issue could further undermine already strained economic relations between India and the United States.

Technology executives and trade groups have discussed approaching Prime Minister Narendra Modi’s office to appraise him of their worries. Separately, the industry is considering pitching the issue as a trade concern, including at the India-U.S. talks in September in New Delhi, according to two sources familiar with the matter.

Though a final decision hasn’t been made, the deliberations come while the United States and India are locked in a dispute over U.S. tariff increases and on the Indian policy of capping prices of medical devices, which hurts American pharmaceutical companies.

“This issue is important enough to be discussed at the India-U.S. trade level,” said Amba Kak, a global public policy adviser at the Internet company Mozilla Corp.

“Data localisation is not just a business concern, it potentially makes government surveillance easier, which is a worry.”

Stricter localisation norms would help India get easier access to data when conducting investigations, but critics say it could lead to increased government demands for data access.

Technology firms worry the mandate would hurt their planned investments by raising costs related to setting up new local data centres.

Greater use of digital platforms in India for shopping or social networking have made it a lucrative market for technology companies, but a rising number of data breaches have pushed New Delhi to develop strong data protection rules.

Shamika Ravi, a member of Modi’s economic advisory council, said data localisation was a global phenomena and India wasn’t an outlier.

“It’s in the long term strategic and economic interest,” said Ravi, who is also a research director at Brookings India.

EXTENSIVE MEETINGS

The main government committee on data privacy last month proposed a draft law, recommending restrictions on data flows and proposing that all “critical personal data” should be processed only within the country. It would be left to the government to define what qualifies as such data.

Global companies are coming together to push back.

In a meeting last week organised by lobby group U.S.-India Strategic Partnership Forum, executives from Facebook, Mastercard, Visa, American Express, PayPal, Amazon, Microsoft and others discussed plans to approach Indian lawmakers, including Indian parliamentary panels on information technology (IT) and finance, five sources said.

The industry also discussed approaching media and internet groups to explain why data localisation would be bad for India’s booming IT, e-commerce and payments landscape, the sources said.

“People are fairly stressed and scared,” said an executive working for a multinational technology firm.

The U.S.-India lobby group said it was “nearly impossible” to implement “industry-specific regulations in our global data environment without the ripples being felt”. It didn’t comment on its recent meeting, but said it will continue facilitating policy discussions.

Mastercard, American Express and Amazon didn’t respond to a request for comment, while Facebook, Microsoft, Visa and PayPal declined to comment.

The Indian bill, which was opened for public comments this week, will later go to parliament for approval.

The U.S.-India Business Council, a lobby group that is part of the U.S. Chamber of Commerce, has brought in the Washington-headquartered law firm Covington & Burling to suggest submissions on India’s data protection law.

The firm’s 43-page draft recommendations, seen by Reuters, listed removing data localisation requirements as a top priority and called New Delhi’s proposed move a “protectionist approach”.

The U.S.-India Business Council didn’t comment on how it would act on the recommendations of Covington & Burling, which declined comment.

The lobby group’s president, Nisha Biswal, however said India’s draft privacy law was of “great importance,” and that the group would share its concerns with the government directly.

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