Articles Posted in Medications

covervf-300x210As the nation’s opioid and drug overdose crisis deepens, it can be hard to watch as the “Not My Fault” crowd clucks about its blamelessness in pushing potent painkillers that have played a part in killing more Americans in 2016 and 2017 alone than lost their lives in the Vietnam War.

The latest NMF protagonists include:

insys-300x141Insys Therapeutics, a drug maker that peddled powerful and addictive painkillers in sordid ways, entered yet another phase of its penalties for its criminal conduct: The firm in quick fashion agreed first to pay $225 million to resolve federal bribery charges, then promptly sought bankruptcy protection.

Federal prosecutors, who earlier had won criminal racketeering convictions against the firm’s CEO and other Insys executives, emphasized that the Big Pharma firm hasn’t declared itself insolvent in its bankruptcy action and will pay up for damages caused by Susbsys, its chief product.

Subsys is a liquid containing the super potent painkiller fentanyl. It is administered as a drop under the tongue and was supposed to benefit cancer patients with grueling pain. Instead, Insys CEO John Kapoor “used speaker’s fees and lap dances to lure doctors into prescribing Subsys for far more patients than the drug was approved for and cheated insurers into covering prescriptions for the costly medication,” the Washington Post reported. Kapoor and other Insys execs await sentencing after their federal felony convictions.

cbdThe federal Food and Drug Administration has waded into its potential oversight of a substance that already is becoming wildly popular. The process of figuring government rules for cannabidiol, aka CBD, well could be called Confusion By Design.

The New York Times and Washington Post both reported on the parade of dozens of parties, pared from hundreds of aspirants, wanting to influence the FDA’s path with the agency’s first hearing on CBD. It already is sold in thousands of products on the market now. These include pet foods, soft drinks, bath salts, and oils and solutions that users add to food and rub on themselves.

Of great concern to the FDA are the extreme and proliferating claims that vendors are making for unproven health-related benefits of use of CBD, which is a nonintoxicating extract that can be derived from hemp and marijuana. As the popular health information WebMD site reported:

lyrica-300x248Patients’ struggles with medical pain are a major problem. So, too, is the proclivity of Big Pharma, doctors, hospitals, insurers, and many others to respond to pain not only by pushing more prescription pills but also by overstating their benefits and downplaying their costs and potential harms.

As the nation grapples with an opioid painkiller crisis, New York Times columnist Jane E. Brody deserves credit for drilling down on gabapentin, “taken by millions of patients despite little or no evidence that it can relieve their pain.”

The drug won approval from the federal Food and Drug Administration a quarter century ago for treatment of seizure disorders. But it since has become a go-to medication for doctors who write “off-label” prescriptions for it to care for “all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems,” Brody wrote.

pills-300x200With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes, however, may be dying out by the day.

The attorneys general of dozens of states have sued major generic makers including Teva, Pfizer, Novartis and Mylan, accusing them of conspiring to inflate generic drug prices by as much as 1,000%, the New York Times and other media organizations reported.

The makers’ price-fixing affected more than 100 generics, including “lamivudine-zidovudine, which treats H.I.V.; budesonide, an asthma medication; fenofibrate, which treats high cholesterol; amphetamine-dextroamphetamine for A.D.H.D.; oral antibiotics; blood thinners; cancer drugs; contraceptives; and antidepressants,” the New York Times said.

um-seal-300x300Just as the nation grapples with the worst measles outbreak in a quarter century, the University of Maryland and public health officials are drawing fire for the way they handled the strange confluence of mold infections in dorms and the spread of an contagious virus among students on the College Park campus.

The university and its advisers tried to keep a lid on public information about the dual problems, leading students and parents to assail the school and to blame its sluggish response and silence for the death of an immune-compromised coed.

Her death late last year — following the fall heat-stroke fatality involving Jordan McNair, a 19-year-old football player — has renewed concerns that the university and its staff may lack the expertise, training, and sensitivity to protect vulnerable young people, the Washington Post reported as part of its investigation of the confused health scenario involving Olivia Shea Paregol.

JohnKapoor-221x300

Even as more felony charges may follow in drug epidemic, sleep med warning suggests pill popping stays too popular

Five top executives at a major drug maker have been convicted of criminal racketeering for their aggressive and deceptive marketing of a fentanyl spray in a case that prosecutors long have said may warn corporate leaders about their culpability in the nation’s opioid painkiller crisis.

Federal jurors deliberated for 15 days before finding guilty John Kapoor, founder and CEO of drug maker Insys (shown at right). Jurors also convicted Richard M. Simon, former Insys national director of sales; Sunrise Lee and Joseph A. Rowan, both former regional sales directors; and Michael J. Gurry, former vice president of managed markets. As the New York Times described the case against them:

doud-300x175An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths. Prosecutors now are saying  that at least some of the causes of this crisis are nothing less than criminal behavior by people wearing white coats and ties.

Federal and state prosecutors are bringing felony charges against doctors and Big Pharma executives as if they were street drug dealers and crime bosses.

This formal faulting for the nation’s opioid crisis hasn’t yet spread widely among drug makers, those at the pinnacle of the pharma pipeline. The legal war, however, has resulted in aggressive steps by federal prosecutors accusing not only scores of doctors across seven states with improperly prescribing painkillers for cash and sex, but also with officials filing for the first time drug-trafficking charges against a major pharmaceutical distributor and two of its former executives.

Candida-aurisWhen big hospitals are locked in bare-knuckle battles against debilitating and deadly bacterial and fungal infections sweeping their institutions, don’t patients have the right to know about these situations that might affect their lives and care? According to some hospital insiders, no.

The New York Times reported that a “culture of secrecy” prevails in hospitals as they combat “super bugs,” bacteria that have become resistant to antibiotics and now fungi that have evolved immunities to antifungals.

The newspaper found the institutional opposition to making public outbreaks of hospital-borne infection as it followed up its own scary page one story about the global spread of Candida auris, a drug-resistant fungus that preys on patients who already are hospitalized and may have compromised immune systems.

kneestemcell-300x169When doctors and regulators crack down on the burgeoning and risky use of purported stem cell therapies, some well-known and respected big hospitals and health systems may have their own practices to explain, too.

As Liz Szabo reported for the nonpartisan Kaiser Health News Service:

Swedish Medical Center, the largest nonprofit health provider in the Seattle area … is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information