Henrietta Lacks (Via Johns Hopkins Medicine)

Es­tate of Hen­ri­et­ta Lacks sues Ther­mo Fish­er over the im­prop­er sale of her im­mor­tal cells

The fam­i­ly of a black woman whose im­mor­tal cells were un­eth­i­cal­ly tak­en from her at Johns Hop­kins hos­pi­tal in 1951 is now su­ing Ther­mo Fish­er Sci­en­tif­ic for prof­it­ing from the cells for decades.

The world-fa­mous cell line, known for Hen­ri­et­ta Lacks as HeLa and the sub­ject of a best­selling book about a decade ago, have proven to be in­cred­i­bly im­por­tant in hu­man his­to­ry, help­ing sci­en­tists to make ma­jor strides, from the po­lio vac­cine to in vit­ro fer­til­iza­tion.

But the fam­i­ly be­hind the cell line is tak­ing par­tic­u­lar is­sue with the prof­its Ther­mo Fish­er has made thanks to their an­ces­tor’s ge­net­ic ma­te­r­i­al.

At­tor­ney Ben Crump, cen­ter, holds Za­y­den Joseph, 6, the great-grand­son of Hen­ri­et­ta Lacks, while stand­ing with at­tor­neys and oth­er de­scen­dants of Lacks, whose cells have been used in med­ical re­search with­out her per­mis­sion, out­side the fed­er­al cour­t­house in Bal­ti­more, Mon­day, Oct. 4, 2021. They an­nounced dur­ing a news con­fer­ence that Lacks’ es­tate is fil­ing a law­suit against Ther­mo Fish­er Sci­en­tif­ic for us­ing Lacks’ cells, known as HeLa cells. (AP Pho­to/Steve Ru­ark)

Click on the im­age to see the full-sized ver­sion

“Ther­mo Fish­er Sci­en­tif­ic lit­er­al­ly sells Ms. Lacks’ cel­lu­lar ma­te­r­i­al, de­vel­ops and man­u­fac­tures cel­lu­lar prod­ucts in­cor­po­rat­ing HeLa cells, and seeks in­tel­lec­tu­al prop­er­ty rights on these prod­ucts, stak­ing a claim to the ge­net­ic ma­te­r­i­al of Ms. Lacks,” the suit filed in Mary­land dis­trict court on Mon­day says. “Ther­mo Fish­er Sci­en­tif­ic has ap­pro­pri­at­ed Ms. Lacks’ ge­net­ic ma­te­r­i­al for its own pe­cu­niary gain, all with­out pay­ment, per­mis­sion, or ap­proval from the Lacks Es­tate or fam­i­ly.”

While Johns Hop­kins has main­tained that it nev­er prof­it­ed from the cell line, the fam­i­ly has pre­vi­ous­ly sought pay­ment from the uni­ver­si­ty for use of the line. The es­tate’s suit against Ther­mo al­so notes the com­pa­ny’s in­tent “to prof­it from the un­law­ful con­duct” of the Johns Hop­kins doc­tors.

Erin O’Shea

“Ther­mo Fish­er Sci­en­tif­ic’s choice to con­tin­ue sell­ing HeLa cells in spite of the cell lines’ ori­gin and the con­crete harms it in­flicts on the Lacks fam­i­ly can on­ly be un­der­stood as a choice to em­brace a lega­cy of racial in­jus­tice em­bed­ded in the US re­search and med­ical sys­tems. Black peo­ple have the right to con­trol their bod­ies. And yet Ther­mo Fish­er Sci­en­tif­ic treats Hen­ri­et­ta Lacks’ liv­ing cells as chat­tel to be bought and sold,” the suit says.

The suit comes as the Howard Hugh­es Med­ical In­sti­tute in Mary­land gave the Hen­ri­et­ta Lacks Foun­da­tion a six-fig­ure gift in 2020, with HH­MI pres­i­dent Erin O’Shea ac­knowl­edg­ing “that we have a long way to go be­fore sci­ence and med­i­cine are re­al­ly eq­ui­table.”

At a press con­fer­ence in Bal­ti­more on Mon­day, one of the fam­i­ly’s lawyers al­so said re­lat­ed claims may be filed against oth­er com­pa­nies prof­it­ing from the HeLa line, ac­cord­ing to the As­so­ci­at­ed Press.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

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While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

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The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

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On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.