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Aug
17
Sandeep Singh Dhillon
Goldman Sachs breaks down how Amazon can jump into health care – CNBC
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By Christina Farr, CNBC

Amazon is speeding its efforts to crack the health care market, hiring a number of high-profile executives, testing Echo technology in top hospitals and creating a secret “1492” team dedicated to health-technology opportunities like telemedicine and electronic medical records.

Goldman Sachs is now out with a 30-page report from five research analysts on Amazon’s likely ambitions in the $560 billion prescription drug market. The note cites CNBC’s reporting on the 1492 group and Amazon’s hiring of a general manager to lead its pharmacy unit.

Here are some of the key insights from the report:

  • Rather than replacing pharmacies right away, Amazon might start by partnering with a pharmacy benefits manager (PBM), which acts as an intermediary between payers, like health insurers, and the rest of the health system. That would provide “access to patient data and the potential to cross-sell related products.”
  • Amazon could ultimately improve price transparency for the consumer and reduce out-of-pocket drug costs. But it would likely start by speeding up the drug delivery process and facilitating at-home delivery.
  • Amazon could also become an online pharmacy, retail and online pharmacy, integrated PBM and online pharmacy, or handle drug distribution to pharmacies.
  • One potential — and overlooked — challenge for Amazon might be the so-called “age gap.” Amazon’s customers tend to be younger and healthier than people who typically take prescription drugs.
  • Amazon could move into digital health by using the Echo in clinical settings and developing tools for telemedicine and remote patient monitoring. “Imagine seeing a virtual doctor on your Amazon app, having it prescribe you a certain medication, and then tapping a ‘buy now’ button — all without leaving your home.”

Jul
31
Sandeep Singh Dhillon
GlaxoSmithKline’s new boss streamlines R&D, axes slew of drugs – Reuters
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Ben Hirschler

LONDON (Reuters) – GlaxoSmithKline’s new chief executive announced plans on Wednesday to narrow the focus of the group’s drug research by ditching more than 30 drug projects to improve returns in its core pharmaceuticals business.

Emma Walmsley, who took over in April, said GSK would in future allocate 80 percent of its R&D budget to respiratory and HIV/infectious diseases, along with two other potential areas of oncology and immuno-inflammation.

Thirteen clinical and around 20 pre-clinical programmes will be stopped, partnered or divested, and the group is considering options for its rare diseases unit after a strategic review.

It also plans to stop selling the struggling diabetes drug Tanzeum and end a collaboration with Johnson & Johnson over experimental rheumatoid arthritis drug sirukumab, as well as divesting around 130 old drugs with limited sales.

GSK has lagged behind rivals recently in producing multibillion-dollar blockbusters and has suffered a number of high-profile failures, undermining faith in its R&D skills.

“We’ve been too broadly spread,” Walmsley told reporters, adding that the overhaul would not result in a lower R&D budget because GSK had been investing too little in individual experimental drugs in the past.

Indeed, spending could rise as Walmsley and her team go shopping for promising early-stage experimental drugs to bolster the pipeline in GSK’s priority areas.

The announcement came as Britain’s biggest drugmaker reported a 12 percent rise in adjusted earnings per share in sterling terms to 27.2 pence on sales up 12 percent at 7.32 billion pounds ($9.53 billion).

Analysts, on average, had forecast EPS of 26.2 pence and sales of 7.26 billion pounds, according to Thomson Reuters data.

The group reiterated its outlook for 2020, first given in 2015, forecasting sales growth of low-to-mid single digits and adjusted earnings of mid-to-high single digits on a constant currency basis.

For 2017, it now sees EPS growth of 3-5 percent, against 5-7 percent predicted previously, following investment in a “priority review voucher” to accelerate U.S. approval of a new HIV medicine.

Shares in the group fell 1.3 percent by 1400 GMT, with some investors disappointed that Walmsley had not taken the opportunity to increase long-term financial targets.

Given that she announced an extended cost-cutting programme to deliver an additional 1 billion pounds of annual cost savings by 2020, UBS analyst Michael Leuchten said the cautious approach “suggests tougher underlying trends”.

Following Astrazeneca

Walmsley, who previously headed GSK’s consumer health unit after 17 years working for L’Oreal, is known for her focus on benchmarking business performance and had been expected to revamp pharma R&D.

She had previously said she was considering the divestment of older antibiotics and planning to sell two UK nutritional brands.

Overhauling GSK’s R&D machine is her biggest task, however, and she wants scientific and commercial teams to work closely together to pick winners.

The changes will take time to deliver results but Walmsley does have a window as GSK is not expecting its next wave of new drugs until after 2020. It also has no further major patent expiries until 2026.

To some extent GSK is following in the footsteps of its smaller British rival AstraZeneca, which has divested a large number of non-core drug projects recently. Significantly, former AstraZeneca executive Luke Miels, who joins in September, will be a key lieutenant for Walmsley during the shake-up.

GSK benefited once again in the quarter from a weak pound, after last year’s Brexit vote, as well as strong demand for HIV medicines and the failure, so far, of generic firms to win U.S. approval for copies of its inhaled lung drug Advair.

But HIV competition is set to increase next year and U.S. generics to Advair, which has generated more than $1 billion in annual sales for GSK since 2001, are likely by mid-2018.

The company extended a commitment to pay its current 80 pence per share annual dividend through 2018.

(This version of the story adds dropped first name of CEO in second paragraph)

Additional reporting by Kate Holton, editing by Louise Heavens and Adrian Croft

Jul
28
Sandeep Singh Dhillon
MSD Malaysia launches dual-mechanism drug that significantly lowers LDL-C levels – MIMS Malaysia
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MSD Malaysia has recently announced the approval of ATOZET, a combination of ezetimibe and atorvastatin in Malaysia, on 26 July – at a media launch, held at Ruyi & Lyn, Bangsar, KL. The event was graced by consultant cardiologists, Dr Jeyamalar Rajadurai and Dr David Quek, who shared further insights into the prevalence of hypercholesterolemia, disease complications and advisory on hypercholesterolemia management.

The once-daily combination tablet boasts a dual mechanism of action, treating two main sources of cholesterol in the blood. Ezetimibe inhibits the absorption of cholesterol in the digestive tract, while atorvastatin inhibits the production of cholesterol in the liver. ATOZET is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with statin or not.

It is also indicated as an adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) and homozygous familial hypercholesterolemia or mixed hyperlipidaemia in patients not appropriately controlled with a statin alone, or already treated with a statin and ezetimibe.

“Heart disease has been the main cause of death in both men and women. In addition, it is two and a half times more common than all cancers combined for more than a decade. It is a very important cause of premature mortality in both and women below the age of 70. And, one important cause of cardiovascular disease is high cholesterol,” shared Dr Jeyamalar.

High levels of hypercholesterolemia within the Malaysian population

According to the National Health & Morbidity Survey 2015, the overall prevalence of hypercholesterolemia – both known and undiagnosed – among young adults aged 18 years and above in Malaysia was 47.7%. There was a general increasing trend with age: from 22.0% in the 18 – 19 years age group, reaching a peak of 68.8% among the 55 – 59 years age group.

“From above 30 years, there is a huge jump in the prevalence of hypercholesterolemia. In fact, in a survey that was done among 13-year-old students… it was discovered that 23% of these students had high cholesterol levels. We are talking about one in four 13-year-olds with cholesterol levels of more than 5.2mmol,” she explained, depicting the dire situation of heart health in Malaysia.

A REALITY Asia study which examined treatment patterns, goal attainment and factors influencing treatment among patients in six Asian countries who were taking statins, also saw more than half of the participants (particularly in patients at highest risk of various cardiovascular disease, including those with CHD or diabetes) did not accomplish the recommended levels of LDL-C.

Reducing LDL-C levels by 27%

There is evidence suggesting that lower LDL-C levels are associated with fewer CV events: the greater the LDL-C reduction, the greater the CV risk reduction. These benefits related to LDL-C reduction are not specific to statin therapy. Therefore, it seems appropriate to reduce LDL-C as low as possible, at least in patients with very high CV risk,” elaborated Dr David Quek.

ATOZET has been shown in multiple studies to effectively lower LDL-C levels. In a 6-week, multicentre, double-blind, randomised, parallel-group study, ATOZET was shown to provide significantly greater LDL-C reduction (27%) in 196 patients with hypercholesterolemia – compared to doubling the dose of atorvastatin alone.

Additionally, the IMPROVE-IT study which evaluated the clinical benefit of ezetimibe/simvastatin combination compared to the simvastatin alone, has revealed that the combination provided incremental benefits in reducing the many cardiovascular-related risk factors in 18,144 acute coronary syndrome (ACS) patients ̶ a relative risk reduction of 6.4%.

“With the launch of ATOZET, we hope this will enable healthcare professionals to think beyond statin monotherapy when treating patients struggling to achieve their cholesterol level goals. The combination of ezetimibe and atorvastatin in ATOZET represents a new breakthrough, which MSD hopes will aid in addressing the critical unmet needs of patients in Malaysia,” expressed Chris Tan, Managing Director and Zone Leader for Malaysia, Singapore and Brunei at the official launch of ATOZET. MIMS

Jul
5
Sandeep Singh Dhillon
US Pharma Looks at Blockchain Tech to Track Prescription Drugs – Cryptocoinsnews.com
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U.S. Pharmaceutical companies and the Food and Drug Administration (FDA) could soon track prescription drugs over an interoperable blockchain as a means to detect and put an end to counterfeit medicines in the market.

The solution comes from San Francisco-based blockchain startup Chronicled and its partnership with LInkLab, a life sciences supply chain. The two companies have launched a blockchain “track and trace” pilot at a recent one-day event in San Francisco. Developed for the pharmaceutical industry, the solution could prove a viable means to curbing counterfeit drug distribution and sales in the United States and beyond.

Attended by representatives from global pharma manufacturers, wholesalers and hospitals, the blockchain pilot event also saw participation from enterprise IT giants and blockchain tech companies. The event, according to Chronicled, marks the first phase of a pilot to develop an interoperable blockchain platform for the pharmaceutical industry.

Chronicled co-founder and chief performance officer Samantha Radocchia stated in a release:
We will be working closely with teams at leading enterprise blockchain projects over the coming months to identify the most suitable enterprise blockchain to serve as a data utility for the pharmaceutical industry.

The blockchain platform will adhere and satisfy the FDA’s Drug Supply Chain Security Act, signed into effect by former US President Obama in November 2013. The act was and signed to ‘develop an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.’

With this in mind, the blockchain solution will developed to support and comply with DSCSA protocols. Further, the pilot solution will focus on data privacy while adhering to GS1 standards, a global standardized system for traceability that can be implemented by all participants in a supply chain across borders globally.

Altogether, the blockchain tech solution aims to standardize a less expensive, less cumbersome and more efficient and secure approach to facilitate prescription drug distribution.

“The first phase of this project is to prove that one global pharmaceutical manufacturer can comply with their DSCSA regulatory obligations and meet the 2017 and 2023 requirements,” stated Susanne Somerville, co-founder of the LinkLab. “We are excited to be partnering with a major pharmaceutical player in this first phase.”

Future phases will foster the involvement of other participants in a typical pharma supply chain process, straight from the manufacturer to the pharmacy and hospitals.

One of blockchain technology’s core offerings that make it a no-brainer for supply chains across industries is its immutable, time-stamped, tamper-proof ledger, accessible by its all or pre-approved participants. Last week, Australia Post, the country’s postal service operator announced a partnership with Alibaba to curb the rise of counterfeit food exports from Australia to China, using blockchain technology to improve traceability.

Jun
30
Sandeep Singh Dhillon
FDA list of Drugs without Generic Competition to Prevent Price Gouging – 2017 Business Insider
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By Lydia Ramsey

The FDA just took a step that could increase competition and prevent price gouging on drugs that seemingly jump in price overnight.

In May, Food and Drug Administration commissioner Dr. Scott Gottlieb said he wanted to make it more difficult for drugs that are off patent to jack up the price of the medication because they don’t face any competition. The biggest example of this was Daraprim, a decades-old drug that then-Turing CEO Martin Shkreli increased in price from $13.50 to $750 a pill.

To keep that from happening in the future, the FDA on Tuesday published a list of more than 200 drugs that have fallen off patent where the FDA hasn’t received any applications for a generic drug version of that drug.

Before now, it wasn’t too clear which drugs had generic alternatives and which didn’t. That left room for drug companies to buy up those drugs without people noticing and quietly raise their prices. The list could help keep a closer eye on the pool of drugs without generic competition. Ideally, other companies could make generic alternatives to increase competion, lower prices, and keep the drugs from becoming the target of price hikes.

“No patient should be priced out of the medicines they need, we must do our part to help patients get access to the treatments they require,” Gottlieb said in a tweet. “Competition and access are foundational elements to continued pharmaceutical innovation, public health improvement,” he said in a follow-up tweet.

The list includes everything from simple chemical compounds to antibiotics, and glucagon hydrochloride, an emergency diabetes drug that raises the level of blood sugar when it falls too low.

Here is the list

https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM564441.pdf

Jun
21
Sandeep Singh Dhillon
How much is pain costing Singapore’s economy? EDGE Market Report Singapore
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SINGAPORE (June 20): Pain conditions are costing Southeast Asian economies about US$44.6 billion ($61.9 billion) in productivity losses on an annual basis – out of which Singapore’s estimated productivity losses make up about US$6.2 billion per year, according to the 2017 Global Pain Index commissioned by GlaxoSmithKline’s (GSK) healthcare division.

This year’s edition of the index features survey responses from 19,000 adults across 32 countries including Singapore, and its findings revealed that Southeast Asian countries rank among the highest in the world for sufferers living with everyday pain, says GSK Consumer Healthcare in a press release on Tuesday.

Through the index’s results, it was found that 85% of Singaporeans interviewed have suffered from head and body pain, with 42% reporting to suffer from body pain on a weekly basis.

Despite this, 61% and 46% of the men and women surveyed, respectively, say they suffer in silence – while a third of Singaporeans interviewed say they would delay seeking relief for their pain by weeks, or perhaps even longer.

This comes as a cost to the city state’s economy of about 2% of the nation’s gross domestic product (GDP) every year due to missed work day and reduced workplace productivity, says GSK.

The healthcare company also finds it surprising that Singaporeans claim to have some of the lowest levels of knowledge of the medicines available to treat their pain as compared to their global peers. This includes a lack of understanding in the subjects of dosings (24%), potential risks (15%), side effects (15%), ingredients (11%), and interactions with other medicines (10%).

The study’s findings show that pain inevitably impacts relationships as well, ranging from “fading into the background” while being out with friends (57%), to having less patience with their children as a result (77%).

“While headaches, body aches and migraines might not seem to have serious consequences, the 2017 GSK Global Pain Index shows that if not managed effectively, pain can have a cumulative impact,” says Yeo Sow Nam, director of The Pain Specialist, Mouth Elizabeth Hospital and Mouth Elizabeth Novena Hospital.

“Despite the availability of many suitable and effective options for treating pain, it is concerning that Singaporeans tend to suffer in silence for longer than they should, causing a huge burden both at a national and individual level especially for those who suffer from pain weekly. It is important that people take effective steps to address their pain.”

Jun
1
Sandeep Singh Dhillon
WHO commends Malaysia’s medical research work – MIMS Malaysia
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Newly-elected WHO director-general, Dr Tedros Adhanom Ghebreyesus has expressed interest in harnessing Malaysia’s medical expertise. The Health Ministry said the World Health Organisation (WHO) is truly impressed with the country’s medical research work and the accessible and affordable healthcare available here.

“WHO is looking into harnessing our expertise based on this unique model of the research ecosystem in Malaysia to bring down the cost of medicine. We highlighted crucial issues close to the heart of many in developing countries such as cost and access to diagnostics and medicine, where we are convinced that this new partnership model can close the gap of equitable access to medicine,” said Datuk Dr Noor Hisham Abdullah, the Health director-general.

He also took to social media to relay Ghebreyesus’s fascination with this country’s work on Hepatitis C treatment. This programme is in partnership with the global non-profit organisation, Drugs for Neglected Diseases Initiative.

Medical research a valuable field

Despite progression in research, the country still faces some barriers to producing high quality data. A healthcare professional weighed in on this issue recently and described that a basic skill set to conduct good research is required and should be identified in potential researchers.

The medical expert also explained that a large chunk of studies published comes from high-income countries with a Caucasian population. Thus, data from these places might not suit our population entirely and local research would prove beneficial. Another barrier faced here would be low number of cases per hospital and thus, effective research sample sizes are reduced and the study’s significance might be questionable.

Health minister advocates for zero hunger and good health

Health Minister Datuk Seri Dr S. Subramaniam said courageous steps are required as advocators to address the co-benefit of innovative public policy for health. Speaking at the 70th World Health Assembly (WHA) last week, he stated that a better, sustainable health system can be built when our view of the system goes beyond healthcare.

Subramaniam also said at the WHA in Geneva, Switzerland that pollution and climate change are not merely environmental issues once it changes the pattern of communicable disease. This is because Arbovirus infections such as dengue can spread beyond its usual temporal and geographical boundaries.

“A hungry world, a polluted world or a world where women do not stand equally cannot be defined or considered as a healthy world. Achieving zero hunger and good health goes hand in hand. In our passionate search for new vaccine and medical technology, we must remember that no vaccine can prevent the detrimental effect of famine and no medicine can replace the damaging effects of stunted growth,” he added. MIMS

May
29
Sandeep Singh Dhillon
Blood-Based Breast Cancer Detection Test May Help Avoid Biopsy – Forbes
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By John Nosta

Early detection of cancer is one of the most powerful tools in the management of this disease. And while imaging modalities have advanced the ability to detect early disease, challenges still exist for both clinician and patient. Yet one point remains clear and is a driving principle—early detection saves lives. And the earlier, the better.

A study published in Clinical Breast Cancer examined the utility of blood markers to detect breast cancer. The test that was evaluated is called Videssa Breast and evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies. It was studied in women under 50 who had abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4).

Here’s the overall takeaway: The negative predictive value—the likelihood of a patient having no cancer—was 99%. In other words, clinicians may have a powerful tool to identify patients who are highly unlikely to have breast cancer, in instances where the mammogram is abnormal. Overall, imaging resulted in 341 participants receiving follow-up procedures to detect 30 cancers (90.6% FP rate). Videssa Breast would have recommended 111 participants for follow-up, a 67% reduction in false positives. The authors conclude:

Videssa Breast can effectively detect breast cancer when used in conjunction with imaging and can substantially reduce unnecessary medical procedures, as well as provide assurance to women that they likely do not have breast cancer.

While the results are impressive, the clinical path itself can be difficult. Primary care physicians, radiologists and surgeons all play a role in patient management. And the decision for invasive procedures such as a biopsy involves these stakeholders—and the patient. I presented the study to three of these decision-makers for their perspective on a blood-based test used in association with mammography.

The primary care physician:

I see these diagnostic uncertainties after breast cancer screening almost daily. When a mammogram comes back abnormal, I can tell my patient that it appears benign. But with Videssa Breast, I can give her much more powerful reassurance that it is not cancer. Having used the test for some time, my goal is to educate other providers about it, because I’ve seen it serve as a valuable decision-making tool that helps spare women potentially unnecessary biopsy. Most women who get that abnormal imaging result do not have cancer. With the simplicity of a blood test, I can send more of them home with peace of mind.

—Wendell Phillips, D.O., primary care physician with HonorHealth Medical Group in Phoenix, Ariz.

The radiologist:

As a radiologist, images don’t always give us a clear view of a patient’s cancer status. A blood test that offers clinicians the confidence to rule out cancer can help us better select the patients who truly need closer monitoring or that next intervention. In the case of breast biopsy, the test is a powerful avenue for reducing the use of an invasive procedure and still get to best outcomes for women.

—Josie R. Alpers MD, radiologist and study co-author

The surgeon:

Clearly this type of liquid biopsy test is the direction we are going with many cancers. As mammography technology has improved, we are finding many things that we have to act on, but may be clinically insignificant. I can see that increasing with the adoption of this technology—at least until we have gotten over our learning curve. However, there is no question that patients who have a BIRADS 3 mammogram and high anxiety about six-month follow up may be relieved by a negative Videssa test.

—Deanna Attai, M.D., past president, the American Society of Breast Surgeons

For solid tumors, the combination of an anatomic view and biological view may hold the promise to more sophisticated detection and management. Further, we may also gain new insights into other pathology such as atypical hyperplasia and how to best manage these conditions. But beyond the deeply scientific aspect of cancer detection lie deep personal and emotional aspects of this disease. The burden is tremendous and the ambiguities of diagnosis can add to the difficulties. A new test, particularly one with a high negative predictive value, can be a potent source of comfort that offers, in and of itself, a level of therapeutic value. And as more data become available, the potential for expanded use of Videssa Breast as a screening tool could be a game-changer in the diagnosis and management of breast cancer.

May
19
Sandeep Singh Dhillon
Jeff Bezos’s Amazon Wants a Slice of the Multi billion-Dollar Pharmacy Market – INC.com
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Jeff Bezos’s company is reportedly looking to expand its portfolio to the multibillion-dollar pharmacy market.

Over the past few years, Amazon has held “at least one annual meeting” to evaluate whether it should jump into the pharmacy space, according to CNBC citing sources familiar with the matter. Two weeks ago, Amazon posted a new job looking for a “PHC [Primary Home Care] Licensing Program Manager” to support its “Professional Healthcare Program.” Responsibilities include submitting state license applications and maintaining “documents and databases for state board of pharmacy licensing requirements,” according to the job description. The company didn’t immediately respond to a request for comment.

Amazon also recently announced its plans to hire 5,000 home-based workers to join its customer service teams. The majority of those jobs will come with benefits like health insurance, sick and vacation time, and tuition.

Jeff Bezos’s Amazon empire has expanded into food retail (Amazon Fresh), video streaming services (Amazon Prime), web hosting (Amazon Web Services). It’s also jumped into the rocket ship race with Blue Origins. Last month, Amazon announced its plan to roll out operations in Australia, where online sales are expected to account for more than a third of the country’s retailers’ sales. At last count, the company has invested or acquired more than 128 companies in the last few years.

May
19
Sandeep Singh Dhillon
The world’s largest drugmaker thinks it has 11 billion-dollar drugs in the pipeline : here’s what they treat – Business Insider
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Johnson & Johnson just listed out the drugs it plans to file for approval over the next few years that could be “blockbusters.”

These are drugs that haven’t been approved yet, but by 2021, they could be making more than $1 billion in annual sales each.

Right now, the world’s largest drugmaker is known for its immunology drugs like Remicade, which made $4.8 billion in sales in 2016 and Stelara, as well as the bloodthinner Xarelto, which made $2.2 billion in sales in 2016.

Here’s the list of drugs J&J plans to file for approval over the next four years that could hit that blockbuster threshold, including cancer and depression treatments:

guselkumab – psoriasis (Filed for approval in 2016)
sirukumab – rheumatoid arthritis (Filed for approval in 2016)
apalutamide – pre-metastatic prostate cancer
esketamine – treatment-resistant depression
talacotuzumab – acute myeloid leukemia, a type of blood cancer
erdafitinib – solid tumors
niraparib – prostate cancer
imetelstat – myelofibrosis, a bone marrow disorder
pimodivir – influenza A
lumicitabine – respiratory syncytial virus (RSV) infection
JNJ-7922 – adjunctive treatment for major depressive disorder