Massachusetts Challenges Gilead’s Hepatitis C and H.I.V. Drugs

Maura Healey, the Massachusetts Attorney General, has begun an investigation into the pricing of Gilead Sciences’ Hepatitis C drugs due to possible violations of Massachusetts’ consumer protection laws. Gilead’s Hepatitis C drugs, Sovaldi and Harvoni, have been applauded as “breakthrough” treatments for the disease, curing most patients in 12 weeks with minor side effects. However, the drugs come at a lofty price — anywhere between $84,000 and $94,000 for a course of treatment – which has led Ms. Healy to the conclusion that Gilead’s pricing of the drugs may be resulting in “massive public harm” by making the drugs unavailable to vulnerable populations.  In particular, the demand for the drugs, and with Gilead’s pricing structure, has placed a costly burden on state Medicaid and prison health care programs, causing many such programs to strictly limit access to the drugs.  As a result, Ms. Healy argues, Gilead effectively created a cure for Hepatitis C, but then made that cure unavailable through its pricing structure.

Although Gilead contends that its high prices are offset because Sovaldi and Harvoni may help patients avoid costly liver diseases, and that substantial discounts may be available to certain consumers and insurance companies, this is not the first time Gilead has faced scrutiny of its practices.  The AIDS Healthcare Foundation recently filed a lawsuit against Gilead regarding its HIV drug, Tenofovir, and a lawsuit filed by the Southeastern Pennsylvania Transportation Authority regarding Gilead’s exorbitant prices was recently dismissed.  It remains to be seen whether Gilead has violated any laws, but perhaps the ongoing scrutiny of Gilead’s practices will lead to a mutually beneficial resolution, which Ms. Healy hopes will be a reduction in price.



Pharma Cash Cow: Old Medications, Lucrative Opportunities

In August of this year, the rights to the decades old drug Daraprim were purchased by pharmaceutical company Turing Pharmaceuticals.  Daraprim is the standard of care for treating toxoplasmosis and is used as well in treating HIV infections, cancers, and malaria.  Although the drug was previously sold at $13.50 per tablet, upon its purchase by Turing Pharmaceuticals, the drug’s price increased by over 5,000% to $750.00 per tablet, sparking mass outrage across the internet.

The CEO of Turner Pharmaceuticals, Martin Shkreli, a former hedge fund manager, responded to the widespread criticism of the price increase by providing several reasons for the pricing structure change.  In particular, Mr. Shkreli cited the need to keep the company’s manufacturing costs competitive and to raise capital for the development of new medications to treat toxoplasmosis.  However, medical professionals indicate that there is no need to develop new pharmaceuticals to treat toxoplasmosis and that the former price was profitable, albeit at a much smaller margin.

In response to the public outcry against the price hike, which included criticisms from former Secretary of State Hillary Clinton and presidential candidate and Vermont Senator Bernie Sanders, Turing Pharmaceuticals has reversed the price increase. However, Turing Pharmaceuticals is not the only pharmaceutical company to acquire an old medication and subsequently increase its price to boost profits.  Other drugs, such as Sovaldi, used to treat hepatitis C; Harvoni, a follow-on formulation of Sovaldi for hepatitis C; Retrophin, used to reduce kidney stones; and Cycloserine, used to treat drug-resistant tuberculosis, have also been subjected to similar price increases. Congress is poised to inspect the recent trend in drug price increases, but until congressional action is taken, it appears public outcry will be the primary means of keeping more excessive increases at bay.

To read more about, this click on any of the following links:  LA Times, NBC, NBC News, CBS News

Seattle Man Who Infected at 8 People with HIV Ordered to Stop or Face Jail

A Washington court recently issued a cease-and-desist order against a man, known as “AO,” who is accused of spreading HIV to his sexual partners.   Since his diagnosis in 2008, “AO” has infected at least 8 sexual partners. Although the King County Department of Health previously issued two cease-and-desist orders against the man, those orders were ignored and the agency “felt legal enforcement was the best way to assure the health of the patient and public.” Now, “AO” is under court order to attend HIV counseling centered on adopting safe behaviors to prevent infection of future sexual partners. If “AO” disobeys this order, he could face jail time and escalating fines. This is only the second time in the history of the Seattle public health department that officials used a 1988 state law to restrain a contagious person infected with a sexually transmitted disease.

Read more here.

“Cure” HIV by Speeding Up the Virus’ Mutation?

It has been fifteen years since MIT professor John Essigmann proposed that in order to fight HIV, drugs should be developed that drastically increase the rate of the virus’ mutation. Essigmann’s idea has lead to the current use of inhibitors (drugs that force cells to mutate so quickly they weaken) for HIV treatment. Once HIV infects a cell, it “rapidly makes copies of its genetic material.” Rapid copying causes errors allowing the virus to mutate quickly and evade the immune system. Essigmann hypothesized that the virus could be starved of essential proteins if the mutation process is increased to an even more rapid pace, eventually killing the virus. Current HIV treatments fight the virus using Essigmann’s 15-year old idea of forcing cells to mutate at unsustainable rates, but researchers have not yet been able to completely “cure” patients.

Read more here.

Iowa Reconsiders HIV-Specific Laws; Growing National Trend

In 1990, Congress approved the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. The CARE Act funds support and medical treatment for individuals with HIV. However, under the Act every state had to certify that it had criminal laws that would prosecute individuals with HIV who knowingly exposed others to the disease, even if those exposed did not contract HIV. Individuals who are successfully prosecuted under these laws are listed as sex offenders. In one case in Iowa, a woman was prosecuted successfully even though she claimed that she informed the man that she was HIV positive. He claimed she did not tell him; however, two weeks prior to filing his complaint against her, he was convicted of domestic abuse for hitting her. She is now listed as a sex offender.

Currently, the federal government and advocates consider these HIV-specific laws to be draconian in light of modern scientific knowledge regarding HIV, which is “no longer the death sentence it once was.” Many of these HIV-specific laws do not require exposure in the form of sexual contact, and some even include exposure in the form of something as innocuous as spitting. HIV cannot be transmitted through saliva. Some states, including Iowa, are reconsidering and changing their HIV-specific laws in response to this change in public opinion.

Read more here.

HIV/AIDS Policy in South Africa Increases Risks for Lesbians and Bisexual Woman

Though the risk of sexual transmission of HIV between female partners is assumed to be low, scientific evidence shows that lesbians and bisexuals have an increased risk of transmission of certain reproductive tract infections. Therefore, some lesbian activists in South Africa believe that South Africa has wrongly de-prioritized the risk of HIV infection for lesbian and bisexual women.  Also, these activists believe that South Africa’s stance on this issue reinforces the myth that lesbian and bisexual women do not require the same protective measures during intercourse.

Moreover, about 10 percent of lesbian and bisexual women in South Africa are HIV positive – often, it would seem, a result of forced sex.  To read more, click here and here.

Bone Marrow Transplants Potential “Cure” for HIV?

Two patients, who had been living with HIV for approximately 30 years, have had no detectable HIV in their blood for the last several years— after receiving bone marrow transplants for lymphoma. However, researchers say that it is far too early to claim that the transplants “cure” HIV, and that even if it were possible to use “the C-word,” it is not an attractive option for curing HIV patients in general.

Bone marrow transplants are expensive, and patients that receive them have a 15 to 20 percent mortality rate within the first few years of their transplants. The two HIV-positive patients received bone marrow transplants as a treatment for cancer. Yet, their results suggest that bone marrow holds promise as a treatment for HIV.  Only time will tell if bone marrow offers a cure for people with HIV. Read more here.