Alzheimer’s drug promising? Page 1. Alzheimer’s drug not so promising? Page B12

Not sure how STAT played this on their site. In the the print version of The Boston Globe, it ran it on A1 Thursday

Hopes rise again for a drug to slow Alzheimer’s disease

File Oct 30, 9 54 16 AM

The follow-up in today’s print edition ran on B12, with this headline: Interpreting an Alzheimer’s trial.

Have yet to find in on the Globe web site, but here’s the STAT version, with their headline.

Here’s why Biogen lost $7 billion overnight despite ‘positive’ Alzheimer’s data

 

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Should #STAT take ads from drug industry lobbyists at #PhRMa?

While acknowledging the quality of the reporting at STAT — and the search for new revenue  to support good journalism — Health News Review wonders why The Boston Globe life science spin-off has to take ads from the pharmaceutical industry’s top lobbying group.

Some STAT readers might see PhaRMa as a champion of just another health-related indstat-phrma-sponsorshipustry, like medical software or consulting services.  Others question the industry’s research, pricing and marketing practices as evidence of a commitment to profits over healing and access.

So, HNR argues that the ads allow the “industry to buy juxtaposition to messages that often call their practices into question.”  

Worth noting that my STAT newsletter arrives with different sponsors on different days. Last week’s included J&J, Amgen, a life science software maker, or none at all.

From HNR:

I am sure that STAT allows no editorial influence by this or any other sponsor. Their hard-nosed coverage of pharmaceutical industry news is top notch…

 

But I do not praise their front office decision to accept this sponsorship deal. It startles me and bothers me every time I see that PhRMA logo on the STAT newsletter. And I think it could raise legitimate questions in discerning readers’ minds.  Journalism ethics dictates that one should strive at all costs to avoid even the appearance of a conflict of interest. Was it necessary for STAT to enter into this sponsorship deal?  STAT just introduced a premium subscription plan.  I hope that works for them; maybe it will generate enough income so that they wouldn’t feel compelled to swim in the murky waters of the PhRMA sponsorship deal…

Certainly PhRMA is thrilled with STAT saying “Yes” –  allowing them to buy their way into regular appearances in the STAT newsletter. This is a foot in the door for an industry to buy juxtaposition to messages that often call their practices into question. It would be understandable if any reader’s head was spinning with thoughts of “What’s going on here?”

Two Boston meetings look at the role of patient advocates. They offer two very different perspectives.

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Pharmaceutical manufacturers often  look to patient advocates for help winning approval for new drugs. Their most recent success in this area was the FDA’s approval of a new drug for Duchenne muscular dystrophy. That decision came despite recommendations against approval from FDA staff.

In an editorial, the Boston Globe questioned the FDA’s move while noting that eteplirsen’s “entry into the marketplace represents a major victory for the patient advocacy movement, and is bound to encourage more such engagement in the drug-approval process. Based on the infighting that went on over the Duchenne treatment, that’s going to be challenging for the FDA. It has to find a balance between public opinion and what’s truly in the public interest.” (The Globe also featured a story this week about one of those patient advocates.)

Today, drug makers in Boston are hosting a conference for patient advocates. The “Patient Advocacy Summit 2016 – Sharing Our Stories: Building a Patient-Centered Ecosystem” is underway at Novartis facility near MIT.

This event brings industry leaders together with patient advocates and other stakeholders to examine ways in which life sciences companies can more fully incorporate the patient voice into the work they do— not just approaching regulatory applications or at commercialization, but throughout the drug development cycle.

The day-long event will include panel discussions, case study presentations (spotlighting industry/patient partnerships), a keynote address, and awards ceremony, as well as a networking breakfast, lunch and cocktail reception. Expected attendance is 180 patient advocacy professionals, patient organizations and other stakeholders.

Worth noting that the same topic was the subject of  yesterday’s  panel at HUBweek, a  science/tech/arts series ongoing in Boston. The title: “The FDA and the Drug Approval Process: Is it Really Broken?”  Some made the point —  we should listen to the parents of sick children.  Others offered a different perspective: Patients might be better off in clinical trials with informed consent and free drugs,  rather paying  $300,000 per year for that same, unproven medication with unknown side effects.

Contacted after the panel, Zuckerman, president of the National Center for Health Research in DC,  offered these thoughts:

  1. Patient perspectives are crucial in helping us understand what scientific data mean, what the benefits and risks both mean to patients.  So patients should be part of the process – what should the outcome measures be and how can they be measured?
  2. The FDA is listening to patients who desperately want treatments but they are not listening well to patients who are harmed by ineffective or unsafe treatments.  That’s partly because the former are funded by Pharma to attend FDA meetings and to lobby Congress, but the latter are on their own, often don’t have the money to attend FDA public meetings, and wouldn’t even know about them if they don’t read the Federal Register, which is the only place they are announced in advance.

 A few more tweets worth noting.

 

Boston news from #BIO2015: Will old labs make good housing? Do expensive drugs reduce health costs?

Over here in Kendall Square, pharma has invested a lot of money in buildings that look like they were designed by Ikea. If this bubble is about to burst, as suggested below, the city could use some nice low-rise housing. photo2 (1)

This story also includes the argument that pricey drugs save the system money by, for example, curing HepC patients and keeping them out of the hospital. Will the push by insurers to pay for effectiveness put some numbers to that claim?

More From Robert Weisman.

PHILADELPHIA — The funding model for drug development is under severe strain as venture capitalists shift money to safer investments, the US government bankrolls less basic research, and a backlash builds against high-priced medicines, a panel of biotechnology industry leaders warned Monday.

Joshua Boger, founder and former chief executive of Vertex Pharmaceuticals Inc. in Boston, said drug companies should be enjoying a reputation for helping the health care system to save money by keeping patients healthy and out of the hospital.

“We’re the cost-lowering part of the medical world, and instead we’ve taken on the role of the whipping boys on cost. And it’s just not true.” Boger said.

Health insurers and lawmakers have complained about the high cost of new specialty medicines such as the hepatitis C drug Sovaldi, which can cost $1,000 per pill. Vertex itself charges more than $300,000 per patient each year for a drug that treats some cystic fibrosis patients

Kendall Square: Worker’s Paradise!

 

Or East Cambridge as The People’s Republic of Pharma

A mural outside the Biogen Idec construction site.

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In Massachusetts, lighter pharma gift ban may = higher costs for consumers #HCR #mapoli

  1. As the Globe story below notes, “A longstanding ban against the coupons in Massachusetts — the last state to prohibit them — was lifted as part of the state budget signed by Governor Deval Patrick on July 8.”This story is behind the pay wall, but here’s the nut: “But some consumer advocates and analysts say the coupons could drive up health care costs at the very time state lawmakers are striving to rein them in. They say discounts will encourage use of brand-name drugs instead of less expensive alternatives, with one estimate showing drug costs for employers, unions, and health plans in Massachusetts could rise by hundreds of millions of dollars over the next decade as a result.”

  2. The industry addressed the issue in general terms here:
  3. The restaurants are not alone in opposing the ban.
  4. More from the opposition

Boston docs on debate over cholesterol screening for kids

A couple of Boston-area docs weigh in on charges of industry influence in the debate over whether to test kids for cholesterol.  From the Globe:

CHICAGO — Should all US children be tested for high cholesterol? Doctors are still debating that question months after a government-appointed panel recommended widespread screening that would lead to prescribing medicine for some kids.

Fresh criticism was published online Monday in the journal Pediatrics by researchers who say the guidelines are too aggressive and were influenced by panel members’ financial ties to drug makers.

Other criticism was published earlier this year in the Journal of the American Medical Association. …JAMA included additional criticism from a dissenting member of the panel that produced the kids’ cholesterol guidelines, Dr. Matthew Gillman of Harvard Medical School. He recommends more narrow screening based on family history of cholesterol problems.

… Dr. Sarah De Ferranti, an American Academy of Pediatrics spokeswoman and director of preventive cardiology at Boston Children’s Hospital, said the question should be part of a conversation parents should have with their pediatrician about heart disease risks, including weight, blood pressure, and lifestyle. She said she would have her children tested.

Most of the Peds articles are behind the pay wall. But, UCSF put out a press release on the latest comments. And the NIH guidelines are online.

From NIH: Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents

From UCSF: New lipid screening guidelines for children overly aggressive, UCSF researchers say recommendations fail to weigh benefits against potential harms

Recent guidelines recommending cholesterol tests for children fail to weigh health benefits against potential harms and costs, according to a new commentary authored by three physician-researchers at UCSF.

Moreover, the recommendations are based on expert opinion, rather than solid evidence, the researchers said, which is especially problematic since the guidelines’ authors disclosed extensive potential conflicts of interest.

The guidelines were written by a panel assembled by the National Heart, Lung and Blood Institute (NHLBI) and published in Pediatrics, in November 2011. They also were endorsed by the American Academy of Pediatrics. The guidelines call for universal screening of all 9 to 11-year-old children with a non-fasting lipid panel, and targeted screening of 30 to 40 percent of 2 to 8-year-old and 12 to 16-year old children with two fasting lipid profiles. Previous recommendations called only for children considered at high risk of elevated levels to be screened with a simple non-fasting total cholesterol test.

The call for a dramatic increase in lipid screening has the potential to transform millions of healthy children into patients labeled with so-called dyslipidemia, or bad lipid levels in the blood, according to the commentary by Thomas Newman, MD, MPH, Mark Pletcher, MD, MPH and Stephen Hulley, MD, MPH, of the UCSF Department of Epidemiology and Biostatistics and e-published on July 23 in Pediatrics.

“The panel made no attempt to estimate the magnitude of the health benefits or harms of attaching this diagnosis at this young age,” said Newman. “They acknowledged that costs are important, but then went ahead and made their recommendations without estimating what the cost would be. And it could be billions of dollars.”

Some of the push to do more screening comes from concern about the obesity epidemic in U.S. children. But this concern should not lead to more laboratory testing, said Newman.

“You don’t need a blood test to tell who needs to lose weight. And recommending a healthier diet and exercise is something doctors can do for everybody, not just overweight kids,” he said

The requirement of two fasting lipid panels in 30 to 40 percent of all 2 to 8-year olds and 12 to 16 –year- olds represents a particular burden to families, he said.

“Because these blood tests must be done while fasting, they can’t be done at the time of regularly scheduled ‘well child’ visits like vaccinations can,” said Newman. “This requires getting hungry young children to the doctor’s office to be poked with needles on two additional occasions, generally weekday mornings. Families are going to ask their doctors, ‘Is this really necessary?’ The guidelines provide no strong evidence that it is.”

The authors note that the panel chair and all members who drafted the lipid screening recommendations disclosed an “extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments.” Some of those relevant relationships include paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs such as Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Roche and Sankyo.

“The panel states that they reviewed and graded the evidence objectively,” said Newman. “But a recent Institute of Medicine report recommends that experts with conflicts of interest either be excluded from guideline panels, or, if their expertise is considered essential, should have non-voting, non-leadership, minority roles.”

Evidence is needed to estimate health benefits, risks and costs of these proposed interventions, and experts without conflicts of interest are needed to help synthesize it, according to Newman. He said that “these recommendations fall so far short of this ideal that we hope they will trigger a re-examination of the process by which they were produced.”

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Newman and Hulley have no disclosures. Pletcher has NIH funding to support research on targeting of cholesterol-lowering medications to prevent cardiovascular disease.