Big Pharma’s shelling out big-time to patient organizations: Quid pro quo?

It’s been eight months since Big Pharma executives faced a grilling by the Senate Finance Committee over their pricing decisions. But the scrutiny is far from over—and now, the committee is digging into pharma funding for patient advocacy groups, which have been known to speak in tunes that are music to the industry’s ears.
AbbVie, Bristol-Myers Squibb, Pfizer, Merck & Co., AstraZeneca and Johnson & Johnson together contributed more than $680 million to hundreds of patient groups and other nonprofits last year, according to a Bloomberg examination of data the companies sent to the Finance Committee.
The total tally more than doubled the $321 million the six companies handed out in 2015 and significantly exceeded what the industry itself spent on lobbying. In 2018, the entire pharmaceutical and health products industry—including pharmaceutical benefit managers—spent $283 million in lobbying U.S. lawmakers, according to the independent research group OpenSecrets.

AbbVie’s spending on patient groups contributed the lion’s share of the jump, according to Bloomberg, from well below $100 million in 2015 to about $350 million in 2018. AbbVie, Bristol-Myers and Pfizer ranked as the three biggest spenders.
AbbVie, in a response to Bloomberg, said it’s looking for information about certain conditions targeted by its products when deciding what groups to fund.

The companies handed over their donation data to the Finance Committee after executives testified in February about rising drug prices. Sanofi’s then-CEO Olivier Brandicourt also appeared at the hearing, but the Bloomberg report doesn’t include donation data from the French pharma. During the testimony, Sen. Ron Wyden, the committee’s ranking member, pointed to the connection between Humira sales and AbbVie CEO Richard Gonzalez’s pay as “problematic.”
It’s unclear whether the torrent of cash has affected the patient groups’ stance on pharma-related issues, but they certainly have supported causes that align with the companies’ own.
Patient advocacy groups are meant to educate and provide support services to patients and caregivers. Drugmakers also count on their insights from patients, which can be important in guiding their decision-making, R&D and marketing.
Some groups also promote messages that are beneficial to drug companies, and the large amount of money they’ve collected from the industry raises questions about potential conflicts of interest and the credibility of their own testimony to Congress.
For example, patient groups routinely appear at FDA Advisory Committee meetings to support a new product’s approval. They also speak at public hearings organized by the Institute for Clinical and Economic Review, often saying a negative review by the drug-cost watchdog could keep patients from getting access to a needed treatment.
The Patient Access Network Foundation, which collected the most in donations from the six companies over the past three years, joined dozens of other nonprofits in warning the Finance Committee about proposed changes to Medicare’s Part D benefit. The proposals might be detrimental to “beneficiaries’ costs and access to prescription drugs,” the groups said, as noted by Bloomberg. A spokeswoman for the organization told the news outlet that its advocacy work isn’t influenced by drugmakers.

Earlier this year, several patient advocacy groups rallied in objection to a Trump administration plan that would introduce step therapy in Medicare, essentially requiring patients to try cheaper drugs before moving to more costly ones. The plan would also allow drugs to be kicked off Part D formularies if price hikes are too steep. A Kaiser Health News analysis found that about half of the groups that objected had received funding from the pharmaceutical industry.
Meanwhile, the Justice Department has been investigating pharma donations to certain assistance organizations that help patients afford their medicines. Celgene, Biogen, Gilead Sciences, Pfizer, Johnson & Johnson and Valeant (now Bausch Health), among others, have been roped into that probe.
The federal prosecutors alleged the companies earmarked their donations, requiring the patient charities to use the money to offer copay assistance for their own drugs. Last May, Pfizer agreed to pay $23.8 million to settle the probe around its cancer drugs Sutent and Inlyta and arrhythmia drug Tikosyn.
https://www.fiercepharma.com/pharma/big-pharma-paid-patient-advocates-big-time-there-any-quid-pro-quo

J&J emerges unscathed in retried California talcum powder suit

Facing a raft of talcum powder lawsuits nationwide, Johnson & Johnson has already been on the wrong side of big penalties in New Jersey and California. Two weeks after losing a case in the latter, J&J can take solace in notching another defense win.
A Torrance, California, jury returned a defense verdict to J&J Wednesday in a lawsuit alleging the drugmaker’s talc products caused 60-year-old schoolteacher Carolyn Weirick to develop mesothelioma. The verdict followed a five-week retrial after an original jury failed to reach a decision, according to the Courtroom View Network.
In a statement, J&J applauded the win, which was the drugmaker’s seventh jury trial victory.
“The jury got it right—Johnson’s Baby Powder does not contain asbestos and was not the cause of the plaintiff’s disease,” the company said.

The latest win for J&J comes on the heels of recent setbacks in California and New Jersey courtrooms, which both slapped hefty penalties on the drugmaker.

Most recently, in a separate California verdict earlier this month, a jury leveled a $40 million penalty against J&J, arguing the company’s baby powder contained asbestos and caused a 70-year-old woman to develop mesothelioma.
Just weeks before, a New Jersey jury had ordered the drugmaker to pay $37.3 million to four plaintiffs on the same grounds. In a unique twist, the judge struck J&J’s entire closing argument after the company’s lawyer called the plaintiffs’ attorneys “sinister.”
A J&J spokeswoman said at the time the company would appeal the decision.

Those recent losses pale in comparison to past verdicts for J&J. In 2018, a St. Louis jury knocked the drugmaker with an eye-popping $4.69 billion penalty after a trial that combined the claims of 22 plaintiffs. Other recent losses include verdicts worth $325 million and $25 million in California and New York, respectively. J&J has said it plans to appeal each loss.
Despite those setbacks, J&J has emerged mostly unscathed from the talc litigation with no negative verdicts surviving appeals so far, the company said.
As recently as August, J&J won another defense verdict in Kentucky after a jury rejected claims that talc products from J&J and Colgate-Palmolive caused plaintiff Donna Hayes to develop mesothelioma. It was the first case to reach a jury verdict in the state, and the panel deliberated for just 30 minutes.
https://www.fiercepharma.com/pharma/j-j-emerges-unscathed-retried-california-talcum-powder-suit

FDA OKs OraSure rapid Ebola test

The FDA approves OraSure’s (OSUR +0.4%) OraQuick Ebola Rapid Antigen Test for the presumptive diagnosis of Ebola virus disease. The agency reviewed the company’s application under its De Novo premarket review pathway since there were no predicate devices.
https://seekingalpha.com/news/3505090-fda-oks-orasure-rapid-ebola-test

In new guide to tapering opioids, fed health chiefs eye balanced prescribing

Federal health officials on Thursday released a guide for clinicians who are considering tapering patients’ opioid prescriptions, highlighting the benefits of safe reductions in dosages while warning against abrupt drops for people who have been on the drugs for long periods.
The recommendations come amid concerns that some chronic pain patients’ dosages have been unsafely pulled back and that providers have sometimes abandoned patients. Some experts and advocates have warned that overly aggressive reductions or forced cutbacks have led some patients who are dependent on the drugs to seek out illicit sources of opioids or consider suicide.
The anxiety around prescribing built in response to the opioid crisis, which drove more than 47,000 fatal overdoses in 2017 alone. The crisis was caused in part by some clinicians overprescribing the drugs, leading to cases of addiction in patients and a source of pills that were diverted. Prescribing levels have dropped since 2012, and some advocates have warned that the fear around opioids has left some patients unable to get them.

The new guide marks the government’s attempt to strike a balance between reducing the amount of opioids prescribed and ensuring patients aren’t left behind. It also reflects concerns that prescribing guidelines released by the government in 2016 were misapplied and contributed to inappropriate tapers.
On a call with reporters Wednesday, Dr. Brett Giroir, an assistant secretary at the Department of Health and Human Services, said it was possible to address the roots of the addiction crisis while helping people receive the medications they need.
“It is a false choice to say we can only limit opioid use disorder, or addiction, or have pain control,” he said.

Overall, the guide casts the decision to taper as an individualized one that prescribers and patients should reach together. Tapers may need to go slowly and their effects should be reviewed throughout the process. Patients need to have their concerns addressed, the guide stresses. It even suggests clinicians reiterate to patients that, “I’ll stick by you through this,” and to offer other forms of support.
Successful tapers to lower dosages can lead to improvements in sleep, mood, and overall daily function without leading to a resurgence of pain, according to the guide. But it also describes the risks of rapid tapering on the first of its six pages. It warns that doing so can induce withdrawal symptoms and recommends that abrupt dose reductions only happen when there are concerns about impending overdoses or other life-threatening issues. It also provides examples of when patients and prescribers should consider tapering, including when the drugs appear not to be working for pain control, or when the patient has side effects or starts taking certain other types of medications, including benzodiazepines.
On the call with reporters, Dr. Deborah Dowell of the Centers for Disease Control and Prevention said there are not specific targets that dose reductions should try to hit. Instead, patients and clinicians should find doses where the benefits of opioid use outweigh the risks.
“Tapering success does not mean getting down to zero or to any particular dose,” Dowell said.
While experts widely agree that overprescribing contributed to the opioid addiction crisis, there’s been an ongoing debate about how insistently to pursue tapers for chronic pain patients. Many who have been on opioids for years have grown dependent on the drugs, and it can be difficult for them to come off the medications. It can also be hard to distinguish whether tapering is leading to a return of pain or temporary symptoms of withdrawal.
While some experts have preached caution — in some cases advocating leaving patients at high doses if tapering could throw off their lives — others argue that leaving patients on these doses for long periods is bad medicine. Higher dosages of opioids are associated with overdose risk, and there is evidence that chronic opioid use can leave people more sensitive to pain and contribute to anxiety and depression.

Much of the debate has focused on a set of 2016 prescribing recommendations from the CDC. The guidelines were a measured set of proposals, including that clinicians treating chronic pain try other therapies before opioids and prescribe only the lowest effective dose and duration of the drugs. The CDC suggested that prescribers “work with patients to taper opioid to lower dosages or to taper and discontinue opioids” in cases where the harms of taking the drugs outweigh the benefits.
But after the guidelines came out, insurers, pharmacies, states, and law enforcement agencies started cracking down on high prescribing, often pointing to the guidelines as the source of their policies. Clinicians grew even more nervous about treating chronic pain patients, advocates said, and sometimes dismissed their patients.
Earlier this year, the authors of the CDC guidelines wrote in a follow-up paper that their recommendations had been misapplied. They said that some agencies and companies used the guidelines incorrectly to justify an “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drugs dosages.”
Dowell (who is one of the authors of the CDC guidelines), Giroir, and Dr. Wilson Compton of the National Institute on Drug Abuse also wrote a piece in JAMA Thursday describing the tapering guide. In it, they write that “clinicians have a responsibility to provide care for or arrange for management of patients’ pain and should not abandon patients.”
They add: “For patients who are unable or unwilling to taper and who continue receiving high-dose or otherwise high-risk opioid regimens … close monitoring and mitigation of overdose risk are recommended.”

With a new guide to tapering opioids, federal health officials seek a balanced approach to prescribing

Puma Bio down 6% after Sanders callout on Nerlynx price hike

Puma Biotechnology (PBYI -5.5%) is down, albeit on below-average volume, in apparent response to disparaging comments on Twitter from Presidential hopeful Sen. Bernie Sanders (I-VT) about its 20% price hike on breast cancer med Nerlynx (neratinib).
https://seekingalpha.com/news/3505061-puma-bio-6-percent-sanders-callout-nerlynx-price-hike

Humana up 3% on expanded partnership with Accolade

Humana (HUM +2.8%) will expand its collaboration with personalized health and benefits solutions platform developer Accolade aimed at customizing the Humana with Accolade solution for a broader based of potential customers. Their plan, supported by a $20M investment from Humana, involves a significantly larger geographic footprint commencing next year and beyond (Humana with Accolade is currently available in the Milwaukee, WI and Cincinnati, OH areas).

The companies launched their partnership in March.

https://seekingalpha.com/news/3505063-humana-3-percent-expanded-partnership-accolade

Proposed Drug Price Reform Would Short-Change Rare Disease Patients

A prominent healthcare watchdog has found the solution to high drug prices – or so it claims.
For years, the nonprofit Institute for Clinical and Economic Review (ICER) has analyzed and rated the cost-effectiveness of new drugs. ICER wants insurers and government programs like Medicare and Medicaid to use these ratings to determine which medicines are worth covering. If health plans only cover drugs that provide a good “value” to patients and taxpayers, ICER believes drug expenditures would plummet.

This approach probably would cut short-term spending – but it would also endanger patients, especially those with rare diseases that afflict fewer than 200,000 people. Millions of Americans could lose access to life-enhancing drugs. And research into rare disease treatments would grind to a halt.
For each drug it evaluates, ICER offers a suggested price range based on how many additional months or years of good health the treatment provides to patients. In the United States, ICER recommends that drugs not cost more than $175,000 for each “quality adjusted life year” – 12 months of good health – they deliver.
Rare disease drugs hardly ever meet ICER’s standards. Four out of the five rare disease therapies that ICER assessed between December 2014 and August 2018 were deemed low value.
Consider revolutionary treatments for spinal muscular atrophy or SMA, the leading genetic cause of death for infants. The FDA approved the first therapy for SMA in 2016. Before that, many patients would die before age two. The drug enabled previously immobile children to stand, walk, and breathe more freely. Parents credit the drug with saving their children and enabling them to hit developmental milestones that were previously unreachable.
But ICER recently determined the therapy fell short of “traditional cost-effectiveness” thresholds. To fit within those thresholds, its price would have to drop up to 90 percent.
So are these treatments overpriced? Not at all. ICER assumes innovators would be willing to take a 70 to 90 percent price cut and still find it financially viable to manufacture and distribute a medicine.
This is wildly unrealistic.
On average, it costs $2.6 billion to bring a new drug to market. If public and private health plans used ICER’s cost assessments to deny coverage to certain medicines, drug researchers would have little incentive to develop new therapies.
This is especially true when it comes to drugs for rare diseases, which often affect just a few thousand people. Many companies won’t even roll the dice on rare disease drug research. Consequently, 93 percent of rare diseases lack an FDA-approved treatment.
When companies successfully create rare disease drugs, they must set prices high enough to recover their development costs from a small patient population. As a result, these treatments cost much more per dose than traditional drugs, whose costs can be spread over millions of customers.
ICER doesn’t sufficiently account for this fundamental difference between mass-market and rare disease drugs. Nor does it consider the smaller-than-average size of rare disease clinical trials when declaring them “inconclusive” in determining a drug’s benefits for patients. And it also evaluates drugs before reliable information is available – it is currently reviewing a treatment for Duchenne muscular dystrophy that is still under FDA review.
Despite its limitations, ICER’s approach appeals to policymakers and insurers who want to cut drug spending. They could point to an ICER analysis as an “objective” reason to not cover certain drugs.
This is already happening in the United Kingdom, where officials in the national health system only cover drugs deemed cost-effective. The National Institute for Health and Care Excellence — which uses a framework somewhat similar to ICER’s – routinely recommends denying patients access to potentially life-saving drugs for conditions ranging from cancer to cystic fibrosis.
If the United States adopted a similar approach, 30 million rare disease patients could face similar barriers to treatment almost immediately.
The long-term effects would be even worse. If insurers and government programs stop paying for rare disease treatments, the financial incentive to develop these drugs would evaporate. Research into thousands of rare diseases would dry up, along with patients’ hope for a long, healthy life.
Lowering drug spending is a worthy goal. But not at the expense of stifling research and condemning millions of patients.
Kenneth E. Thorpe is a professor of health policy at Emory University and chairman of the Partnership to Fight Chronic Disease. 
https://www.realclearhealth.com/articles/2019/10/10/proposed_drug_price_reform_would_short-change_rare_disease_patients_110953.html